A Phase Ib/II Study of STAR0602 With Nivolumab in Non-Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma

Background:
Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment.
Objective:
To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC.
Eligibility:
People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment.
Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function.
STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602.
Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests.
Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months.
Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.

开始日期2026-11-04

申办/合作机构

National Cancer Institute

NCT06827613

/ Recruiting临床1/2期

A Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Unresectable, Locally Advanced, or Metastatic Solid Tumors (START-002)

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

开始日期2025-03-24

申办/合作机构

Marengo Therapeutics, Inc.

NCT05592626

/ Recruiting临床1/2期

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.

开始日期2023-01-04

申办/合作机构

Marengo Therapeutics, Inc.

100 项与 Invikafusp alfa 相关的临床结果

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100 项与 Invikafusp alfa 相关的转化医学

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100 项与 Invikafusp alfa 相关的专利（医药）

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项与 Invikafusp alfa 相关的文献（医药）

2025-10-01·Journal for ImmunoTherapy of Cancer

Combination of a novel TCR Vβ chain-directed selective T cell activator with standard of care therapy for head and neck cancer improves antitumor responses and promotes regression of checkpoint-refractory tumor models

Article

Background:

Immune checkpoint blockade (ICB) treatment, alone or in combination with standard anticancer therapies, has led to important progress in the treatment of head and neck squamous cell carcinoma (HNSCC). Yet, a significant proportion of patients with carcinogen-associated HNSCC (human papillomavirus (HPV) − ) develop disease relapse or progression. Effective treatments for patients who have failed standard of care (SOC) treatment are lacking. STAR0602, a selective, bifunctional T cell agonist comprising an antibody targeting Vβ6 and Vβ10 T cell receptors fused to human interleukin-2, has demonstrated clinical activity in anti-programmed death-ligand 1 resistant tumors. A murine surrogate molecule, mSTAR1302, has been shown to induce tumor regression in multiple syngeneic tumor models and enhance antitumor activity in ICB-refractory settings. This study investigates the therapeutic benefit of mSTAR1302 combined with SOC in the mouse oral carcinoma (MOC)1 and MOC2 HNSCC tumor models.

Methods:

C57BL/6 mice bearing MOC1 or MOC2 tumors were treated weekly with mSTAR1302, cisplatin, and α-programmed cell death protein 1 (PD-1) antibody to determine antitumor efficacy and survival benefit. Immune populations and their effector functions were characterized by flow cytometry and cytokine assays. The tumor microenvironment’s immune architecture was analyzed by multiplex immunofluorescence. Gene expression analysis was conducted to gain an understanding of the mechanism of action of the combination therapy.

Results:

Combination therapy with mSTAR1302, cisplatin, and α-PD-1 promoted robust antitumor activity, higher numbers of mice with complete resolution of tumors, and significantly prolonged survival compared with mSTAR1302 monotherapy or SOC treatment in MOC1 and MOC2 tumors. Tumor-free animals from cohorts treated with the combination therapy demonstrated protection against tumor rechallenge and an overall increase in antigen-specific T cells. Tumor growth inhibition was associated with the expansion of Vβ13 CD8 + and CD4 + T cells, characterized by heightened cytotoxic and effector potentials, in both the tumor and the periphery. The therapeutic effect elicited by the combination therapy was strongly dependent on interferon-γ expression. Thus, the combination of mSTAR1302 and α-PD-1 enabled control of tumors that progressed following platinum-containing treatment.

Conclusion:

These findings provide a rationale for the combination of STAR0602 and SOC therapy in the clinical setting for patients with recurrent or metastatic HPV − HNSCC.

2023-11-29·Science translational medicine1区 · 医学

A T cell receptor β chain–directed antibody fusion molecule activates and expands subsets of T cells to promote antitumor activity

1区 · 医学

Article

作者: Renee N. Donahue ; Andrew Bayliffe ; Jacques Moisan ; Jessica Lowry ; Allart Stoop ; Sangeetha Palakurthi ; Roya Servattalab ; Madan Katragadda ; Jian Tang ; E. John Wherry ; Zhen Su ; James L. Gulley ; Yo-Ting Tsai ; Jeffrey Schlom ; Raj Chopra ; Karunya Srinivasan ; Gurkan Guntas ; Jonathan Hsu ; Wei Huang ; Ke Liu

Despite the success of programmed cell death-1 (PD-1) and PD-1 ligand (PD-L1) inhibitors in treating solid tumors, only a proportion of patients respond. Here, we describe a first-in-class bifunctional therapeutic molecule, STAR0602, that comprises an antibody targeting germline Vβ6 and Vβ10 T cell receptors (TCRs) fused to human interleukin-2 (IL-2) and simultaneously engages a nonclonal mode of TCR activation with costimulation to promote activation and expansion of αβ T cell subsets expressing distinct variable β (Vβ) TCR chains. In solution, STAR0602 binds IL-2 receptors in cis with Vβ6/Vβ10 TCRs on the same T cell, promoting expansion of human Vβ6 and Vβ10 CD4 + and CD8 + T cells that acquire an atypical central memory phenotype. Monotherapy with a mouse surrogate molecule induced durable tumor regression across six murine solid tumor models, including several refractory to anti–PD-1. Analysis of murine tumor-infiltrating lymphocyte (TIL) transcriptomes revealed that expanded Vβ T cells acquired a distinct effector memory phenotype with suppression of genes associated with T cell exhaustion and TCR signaling repression. Sequencing of TIL TCRs also revealed an increased T cell repertoire diversity within targeted Vβ T cell subsets, suggesting clonal revival of tumor T cell responses. These immunological and antitumor effects in mice were recapitulated in studies of STAR0602 in nonhuman primates and human ex vivo models, wherein STAR0602 boosted human antigen-specific T cell responses and killing of tumor organoids. Thus, STAR0602 represents a distinct class of T cell–activating molecules with the potential to deliver enhanced antitumor activity in checkpoint inhibitor–refractory settings.

Frontiers in Immunology

Docetaxel enhances Vβ-directed T-cell activation and antitumor immunity mediated by a bifunctional TCR agonist in breast and prostate cancer models

Article

作者: Su, Zhen ; Lee, Jonelle K. ; Rosato, Francesca ; Fabian, Kellsye P. ; Hodge, James W. ; Moisan, Jacques ; Padget, Michelle R. ; Gulley, James L. ; Santiago-Sanchez, Ginette S. ; Katragadda, Madan ; Schlom, Jeffrey ; Bayliffe, Andrew ; Lee, Cailyn

Background:

STAR0602 is a selective bifunctional T cell agonist targeting Vβ6/Vβ10 T-cell receptors fused to interleukin-2, with emerging clinical activity in anti-PDL1–resistant tumors. Its murine surrogate, mSTAR1302, expands Vβ13 T cells and mediates antitumor activity. Docetaxel, beyond its cytotoxic effects, induces immunogenic modulation of tumor cells. We hypothesized that docetaxel-driven tumor sensitization would enhance susceptibility to immune-mediated killing, while mSTAR1302 would expand functional T cell subsets, resulting in coordinated antitumor responses.

Methods:

The therapeutic efficacy and mechanism of action of docetaxel and mSTAR1302 combination therapy were evaluated in 4T1 triple-negative breast cancer and TRAMP-C2 prostate cancer models. Immune profiling, functional assays, and CRISPR-mediated gene knockdown were used to define mechanisms of response.

Results:

Combination therapy significantly reduced tumor burden and improved survival compared to monotherapies in both models. Docetaxel induced immunogenic modulation characterized by upregulation of MHCI, FAS, and TRAIL-R2, enhancing tumor susceptibility to immune-mediated lysis. Mechanistically, TRAIL-R2 expression contributed substantially to antitumor activity, as knockdown attenuated therapeutic efficacy. mSTAR1302 expanded Vβ13+ CD4+ and CD8+ tumor-infiltrating lymphocytes and promoted antigen-specific T cell responses. Depletion studies demonstrated that CD4+ T, CD8+ T, and NK cells collectively mediated the antitumor effects of combination therapy.

Conclusions:

These findings identify a mechanistic axis in which docetaxel-induced tumor sensitization via TRAIL-R2 cooperates with Vβ-targeted T cell expansion to drive coordinated immune-mediated tumor regression. This work supports the clinical evaluation of STAR0602 in combination with chemotherapy and highlights TRAIL-R2–mediated tumor sensitization as a mechanistically defined strategy to enhance immunotherapy efficacy in immune-excluded tumors.

项与 Invikafusp alfa 相关的新闻（医药）

2026-10-23

·PRNewswire

Marengo Therapeutics Presents Phase 2 STARt-001 Results at ESMO 2026 Demonstrating Tissue-Agnostic Single-Agent Activity of Invikafusp Alfa in TMB-H Solid Tumors Mostly Unresponsive to Immune Checkpoint Blockade

Objective responses observed across eight distinct tumor types, including breast, colorectal, endometrial, gastroesophageal junction, gastric, head and neck, non-small cell lung and bladder cancers Tumor shrinkage observed in 56% of evaluable patients, with an 18% objective response rate (ORR) and 60% disease control rate (DCR) across these eight tumor types in a heavily pretreated population Clinical and translational findings provide further evidence that selective Vβ T-cell activation can amplify and expand antitumor immune responses beyond the PD-1 pathway Results complement first-in-human STARt-001 findings simultaneously published today in the peer-reviewed journal Nature Medicine CAMBRIDGE, Mass., Oct. 23, 2026 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), today announced the presentation of Phase 2 results from the STARt-001 clinical trial of invikafusp alfa at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23–27 in Madrid, Spain. The oral presentation, titled "STARt-001: Phase 2 results of invikafusp alfa, a first-in-class T-cell receptor β-chain–targeted bispecific antibody, as monotherapy in patients with TMB-H solid tumors resistant to immune checkpoint blockade," includes clinical and translational findings from the ongoing Phase 2 study. STARt-001 is a Phase 1/2 study evaluating invikafusp alfa, a first-in-class dual T-cell agonist designed to amplify antitumor immunity, as a single agent in patients with unresectable, locally advanced or metastatic tumor mutation burden-high (TMB-H) solid tumors mostly unresponsive to immune checkpoint blockade (ICB). This population includes patients whose tumors progressed following prior checkpoint inhibition, as well as patients with tumor types for which checkpoint inhibitors are not approved or have historically demonstrated limited benefit. The results showed tissue-agnostic antitumor activity across multiple heavily pretreated tumor types, providing further clinical evidence that selective activation of Vβ T-cell populations can generate antitumor responses beyond the PD-1 pathway. The findings are consistent with the tissue-agnostic rationale recognized in invikafusp alfa's second FDA Fast Track Designation, recently granted for TMB-H solid tumors regardless of tissue of origin. "Patients with tumors that are unresponsive to immune checkpoint blockade continue to face a significant unmet need, whether their disease has progressed following prior checkpoint inhibition or checkpoint therapy is not an established treatment option for their tumor type," said Elena Garralda, M.D., Ph.D., Director of the Research Unit for Molecular Therapy of Cancer (UITM) – CaixaResearch at Vall d'Hebron Institute of Oncology and principal investigator of the study. "The Phase 2 results presented at ESMO show a tissue-agnostic efficacy signal with invikafusp alfa across multiple heavily pretreated tumor types. The translational findings also demonstrate selective expansion of Vβ6-positive T-cell clonotypes, along with an increase in tumor-infiltrating lymphocyte clonotypes, supporting the ability of this novel mechanism to generate antitumor immune responses beyond PD-1 biology." Highlights from the Phase 2 STARt-001 oral presentation Objective responses were observed across eight distinct tumor types, including breast, colorectal, endometrial, gastroesophageal junction, gastric, head and neck, non-small cell lung and bladder cancers. Among 62 evaluable patients with heavily pretreated TMB-H solid tumors across these eight tumor types, tumor shrinkage was observed in 56% of patients, with an 18% ORR and 60% DCR. Activity was observed in both ICB-experienced and ICB-naïve patients. ORR and DCR were numerically higher among ICB-experienced patients than among ICB-naïve patients (20% versus 14%, and 68% versus 43%), respectively. Among ICB-experienced patients, responses were observed in tumors with both primary and secondary resistance, with ORRs of 23% and 28%, respectively. Translational analyses showed rapid and reproducible polyclonal expansion of Vβ6-positive T-cell clonotypes following the first infusion, accompanied by increased overlap between blood and tumor clonotypes consistent with trafficking of activated T cells into tumors. These findings further support selective Vβ T-cell activation as a mechanism capable of expanding antitumor immune responses beyond the PD-1 pathway. In 104 patients evaluated for safety, invikafusp alfa showed a manageable tolerability profile consistent with selective T-cell activation. Cytokine release syndrome was mainly Grades 1 and 2, with no immune effector cell-associated neurotoxicity syndrome and no Grade 5 treatment-related adverse events observed. "These Phase 2 results demonstrate the breadth of invikafusp alfa's single-agent activity across biologically distinct, heavily pretreated tumor types and represent an important efficacy signal for this first-in-class mechanism," said Zhen Su, M.D., M.B.A., President and Chief Executive Officer of Marengo Therapeutics. "STARt-001 was designed as a signal-seeking basket study to evaluate this novel biology across a heterogeneous group of tumors. The activity observed across eight tumor types is now informing a focused, evidence-led development strategy in populations where the biological rationale and unmet need are strongest." The tissue-agnostic results presented at ESMO point to the potential breadth of Vβ-directed immunotherapy. Invikafusp alfa was designed to amplify antitumor immunity and is well suited to complement standard-of-care therapies, with the potential for synergistic antitumor activity. Marengo's combination strategy aims to build greater depth in prioritized indications by pairing invikafusp alfa with these therapies while also supporting its long-term vision for invikafusp alfa as a potential immuno-oncology backbone that can be tailored to the right tumor, the right patient and the right therapeutic solution. Additionally, results from the Phase 1 dose-escalation and initial Phase 2 expansion of STARt-001 were published today in Nature Medicine. The publication represents the first clinical report of a Vβ-directed dual T-cell agonist and establishes first-in-human proof that selected germline-encoded Vβ T-cell populations can be therapeutically activated and expanded in patients with advanced cancer. The Nature Medicine publication and ESMO presentation collectively provide compelling evidence for invikafusp alfa and Marengo's broader Vβ-directed immunotherapy strategy. Marengo is advancing invikafusp alfa through a focused clinical strategy spanning biomarker-selected single-agent development and rational combinations in prioritized tumor settings. The company will present interim Phase 2 results from STARt-002, the first clinical study combining a Vβ6-selective T-cell agonist with an antibody-drug conjugate in triple-negative and HR-positive/HER2-negative metastatic breast cancer at the Society for Immunotherapy of Cancer 2026 Annual Meeting. Further analyses from STARt-001 are also ongoing, with a more complete clinical dataset expected in 2027. About Invikafusp Alfa (STAR0602) Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR™ platform, is a first-in-class, bispecific dual T-cell agonist. It is designed to selectively activate a common Vβ T-cell subset shared across most cancers by combining a non-clonal mode of TCR activation with a T-cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing antitumor immunity and enabling durable tumor clearance. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade. Invikafusp alfa has been granted two Fast Track Designations from the U.S. Food and Drug Administration; the first for the treatment of TMB-H colorectal cancer (granted January 2025) and the second designation, which expands invikafusp alfa's Fast Track status to TMB-H solid tumors regardless of their tissue of origin (granted October 2026). About the STARt-001 Clinical Study STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are unresponsive to immune checkpoint blockade, including tumors that progressed on prior PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626). STARt-001 Phase 2 expansion is ongoing to further investigate invikafusp alfa for the treatment of ICB-resistant tumors. About Marengo Therapeutics Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (Tri-STAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com. Contacts: Media | Peg Rusconi I [email protected] Investors | Anne Marie Fields | [email protected] SOURCE Marengo Therapeutics 21% more press release views with Request a Demo

临床结果免疫疗法临床2期快速通道临床1期

2026-10-23

·PRNewswire

Marengo Therapeutics Announces Landmark Nature Medicine Publication Establishing First-in-Human Proof of Vβ-Directed T-Cell Biology and Antitumor Activity

First-in-human results from the STARt-001 Phase 1/2 clinical trial demonstrate selective activation of Vβ6/Vβ10 T cells expands functional effector and memory populations, generating single-agent antitumor activity in heavily pretreated, checkpoint-resistant solid tumors Peer-reviewed findings establish the human biological foundation for invikafusp alfa and validate Marengo's STAR, TriSTAR and MSTAR precision immunotherapy platforms CAMBRIDGE, Mass., Oct. 23, 2026 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), today announced the publication in Nature Medicine of results from STARt-001, the first-in-human Phase 1/2 clinical trial of invikafusp alfa in patients with advanced, heavily pretreated solid tumors. The publication represents the first clinical demonstration that germline-encoded (sequences of DNA naturally present in the body from birth) Vβ T-cell subsets can be selectively activated and expanded as a therapeutic approach in oncology. In patients whose tumors were mostly resistant to prior immune checkpoint blockade (ICB), invikafusp alfa expanded functional effector and memory Vβ6/Vβ10 T cells and generated single-agent antitumor activity across multiple tumor types. The article titled "Bispecific dual T cell agonist invikafusp alfa in solid tumors: the Phase 1/2 START-001 trial," reports findings from the completed Phase 1 dose-escalation and initial Phase 2 expansion cohorts. The results demonstrate a manageable safety profile, selective peripheral and intratumoral expansion of Vβ6/Vβ10 T cells, objective responses across multiple difficult-to-treat tumor types and the establishment of a recommended Phase 2 dose. "These data provide encouraging clinical evidence that selected Vβ6/Vβ10 T-cell populations can be activated and expanded in patients with advanced cancer," said Lillian L. Siu, M.D., Senior Medical Oncologist at UHN's Princess Margaret Cancer Centre and co-lead author of the publication. "The alignment of target engagement, functional T-cell expansion, a manageable safety profile and objective responses across several refractory tumor types provides a rationale for further investigation of this approach and its potential antitumour activity." Key findings reported in the publication include: Completion of Phase 1 dose escalation without reaching a maximum tolerated dose and selection of a recommended Phase 2 dose based on integrated safety, pharmacodynamic and antitumor activity data. Selective, dose-dependent expansion of peripheral and intratumoral functional effector and memory Vβ6/Vβ10 T cells, providing evidence of target engagement and the intended biological mechanism. Confirmed objective responses in heavily pretreated patients with immune checkpoint blockade-resistant tumors, including microsatellite-stable (MSS) colorectal cancer and PD-L1-negative non-small cell lung cancer, settings that have historically shown limited responsiveness to checkpoint inhibition. A manageable safety profile consistent with invikafusp alfa's mechanism of action, with cytokine release syndrome primarily low grade and no treatment-related deaths, no treatment-related non-laboratory Grade 4 adverse events and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). "Publication of these data in Nature Medicine marks the breakthrough moment at which a novel scientific concept becomes a clinically demonstrated therapeutic approach," said Zhen Su, M.D., President and Chief Executive Officer of Marengo Therapeutics. "For the first time, we show that selected germline Vβ T-cell populations can be activated and expanded in cancer patients, generating antitumor activity across biologically distinct, PD-1-resistant tumors. Invikafusp alfa represents the first clinical application of this biology, and these findings provide proof of concept in humans for our broader platform to activate, redirect or deplete selected T-cell populations. As we present updated Phase 2 results at ESMO today and advance our next-generation IO-ADC strategy, we are applying this biology with precision tailored to the right tumor, the right patient and the right therapeutic solution." Invikafusp alfa is the lead clinical asset from Marengo's Vβ-directed platform. Vβ6/Vβ10 T cells are a germline-encoded population expressed consistently across multiple tumor types, regardless of patient age or sex, and enriched among tumor-infiltrating lymphocytes (TILs). Invikafusp alfa therefore has a target that does not depend on any single tumor-specific mutation or antigen. By demonstrating that a selected germline-encoded Vβ subset can be therapeutically modulated in humans, the Nature Medicine publication provides the biological foundation for three complementary approaches: selective activation through STAR, tumor-directed redirection through TriSTAR and selective depletion through MSTAR. Marengo will also present interim Phase 2 results from STARt-002, the first clinical study to combine a Vβ6-selective T-cell agonist with an antibody-drug conjugate in triple-negative and HR-positive/HER2-negative metastatic breast cancer at the SITC 2026 Annual Meeting. Further analyses are also ongoing, with additional clinical data expected in 2027. Dr. Lillian Siu serves as a scientific advisor to Marengo Therapeutics and holds equity in the company. UHN conducts clinical research supported by Marengo Therapeutics. About Invikafusp Alfa (STAR0602) Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR™ platform, is a first-in-class, bispecific dual T-cell agonist. It is designed to selectively activate a common Vβ T-cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T-cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing antitumor immunity and enabling durable tumor clearance. Invikafusp alfa was designed to restore and amplify antitumor immunity in patients who have progressed on, or are insensitive to, prior immune checkpoint blockade. About the STARt-001 Clinical Study STARt-001 is a global Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1–directed therapy. The Phase 2 portion uses biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit. For more information, visit ClinicalTrials.gov (NCT05592626). STARt-001 Phase 2 expansion is ongoing to further investigate invikafusp alfa for the treatment of ICB-resistant tumors. About Marengo Therapeutics Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and autoimmune diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, and three proprietary platforms: Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (TriSTAR) and T cell Depletor (MSTAR), Marengo is working to selectively target the right T cells in the right patients to create a world in which everyone's immune system can defeat cancer and autoimmune diseases. To learn more, visit marengotx.com. Contacts: Media | Peg Rusconi | [email protected] Investors | Anne Marie Fields | [email protected] SOURCE Marengo Therapeutics 21% more press release views with Request a Demo

免疫疗法临床1期临床2期临床结果

2026-10-23

·BioSpace

Early-stage study shows novel immunotherapy may benefit patients with treatment-resistant solid tumours

Phase 1/2 findings published in Nature Medicine demonstrate how selectively activating T cells may offer a new approach to treating advanced cancers that no longer respond to existing therapies. TORONTO , Oct. 23, 2026 /CNW/ -- A first-in-human clinical trial co-led by researchers at University Health Network's Princess Margaret Cancer Centre has found early signs that a novel immunotherapy may help some patients with advanced cancers that no longer respond to existing treatments. The results of the international Phase 1/2 START-001 trial are published today in Nature Medicine . The study evaluated invikafusp alfa to establish its safety, biological activity and recommended dose for further study, while also providing early signals of anti-tumour activity in patients with advanced, treatment-resistant solid tumours, many of whom had stopped responding to previous immunotherapies. Invikafusp alfa is an investigational, first-in-class, selective dual T cell agonist. It is a type of immunotherapy designed to activate two specific subsets of T cells, known as Vβ6 and Vβ10 T cells. These cells make up only about 10 per cent of all T cells but are commonly found within tumours and may play an important role in the immune system's ability to recognize and attack cancer. Unlike immunotherapies that stimulate the immune system more broadly, invikafusp alfa is designed to selectively activate tumour-fighting T cells while limiting activation of other immune cells -- an approach intended to focus the immune response more precisely on cancer, potentially reducing unwanted side effects. Researchers observed selective expansion of these targeted T cells both in the bloodstream and inside tumours, providing early evidence that the therapy acted as intended. "This study gives us early clinical evidence that selectively activating tumour-relevant T cells is possible and can produce anti-tumour activity," says Lillian Siu, Medical Oncologist, Senior Scientist at UHN's Princess Margaret Cancer Centre and a co-senior author of the study. "These are early findings for a new class of immunotherapy, and they need to be confirmed in larger studies. What is encouraging is that we were able to establish a dose for further testing and see responses in a small number of patients with very advanced disease and limited treatment options," added Dr. Siu, who is also a Professor of Medicine at the University of Toronto. Key findings The study treated 58 participants at 10 cancer centres in Canada, France, Spain and the United States. The main analysis included 52 participants across 21 different types of advanced solid tumours. More than half had received four or more previous lines of therapy, and most had previously received immune checkpoint inhibitors, a common type of immunotherapy used to treat cancer. Among the 27 participants treated at the doses selected for further study: 14.8 per cent experienced an objective response , meaning their tumours shrank enough to meet established clinical criteria for a response. 44.4 per cent experienced some degree of tumour shrinkage , even if the reduction was not large enough to qualify as an objective response. Among the 18 participants whose cancers had stopped responding to earlier immunotherapy, 66.7 per cent achieved disease control , meaning their cancer either shrank or remained stable. Responses were observed in several tumour types, including microsatellite-stable colorectal cancer and non-small cell lung cancer with low PD-L1 expression. These cancers can be difficult to treat with currently available immunotherapies. Limitations and future research The Phase 1 portion of START-001 was designed primarily to evaluate safety and identify a dose for further study. The Phase 2 portion is designed primarily to measure early anti-tumour activity. The findings presented here are based on a relatively small and diverse group of participants with different tumour types and treatment histories. Larger studies and longer follow-up will be needed to better understand which patients may benefit, how long responses may last and how the therapy compares with existing treatments. The ongoing Phase 2 portion of START-001 continues to evaluate the therapy in additional patients. Researchers are also exploring other potential applications for invikafusp alfa as part of broader efforts to better detect, monitor and intervene earlier in cancer recurrence. Supported by the Peter Gilgan Centre for Early Cancer Detection Research at UHN's Princess Margaret Cancer Centre, future research may investigate whether immunotherapies such as invikafusp alfa could have benefits earlier in the course of disease. The START-001 study was sponsored and funded by Marengo Therapeutics, developer of invikafusp alfa. The study was also supported in part by the Intramural Research Program of the Center for Cancer Research, National Cancer Institute, National Institutes of Health. Dr. Lillian Siu serves as a scientific advisor to Marengo Therapeutics and holds equity in the company. UHN conducts clinical research supported by Marengo Therapeutics. About Princess Margaret Cancer Centre The Princess Margaret Cancer Centre, part of the University Health Network (UHN) and affiliated with the University of Toronto, is one of the top cancer centres in the world and the largest comprehensive cancer centre in Canada. Recognized globally for its excellence in cancer research, education, and patient care, The Princess Margaret is transforming the future of cancer through world-leading discoveries, clinical innovations, and a commitment to personalized care. Working in collaboration with The Princess Margaret Cancer Foundation and partners worldwide, the centre's scientists, clinicians, and trainees are advancing research, improving outcomes, and bringing hope to people affected by cancer everywhere. For more information, visit About University Health Network UHN is Canada's Hospital -- ranked #2 in the world, #1 in Canada. With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre. As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. UHN is a research hospital affiliated with the University of Toronto. For more information, visit: SOURCE University Health Network

临床结果免疫疗法临床2期

100 项与 Invikafusp alfa 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床2期	美国	National Cancer Institute	2026-11-04
胸腺癌	临床2期	美国	National Cancer Institute	2026-11-04
胸腺上皮肿瘤	临床2期	美国	National Cancer Institute	2026-11-04
胸腺瘤	临床2期	美国	National Cancer Institute	2026-11-04
实体瘤	临床2期	美国	Memorial Sloan Kettering Cancer Center	2025-05-30
晚期乳腺癌	临床2期	美国	Marengo Therapeutics, Inc.	2025-03-24
晚期乳腺癌	临床2期	加拿大	Marengo Therapeutics, Inc.	2025-03-24
三阴性乳腺癌	临床2期	美国	Marengo Therapeutics, Inc.	2025-03-24
三阴性乳腺癌	临床2期	加拿大	Marengo Therapeutics, Inc.	2025-03-24
腹部肿瘤	临床2期	美国	Marengo Therapeutics, Inc.	2023-01-04

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05592626 (START-001, ESMO2026)	临床2期	实体瘤	97	Invikafusp alfa 0.08 mg/kg intravenously every 2 weeks	醖觸夢鬱鏇網獵積艱蓋(膚膚鹽憲窪憲鑰齋觸製) = 淵觸顧鬱繭鑰獵築壓壓鏇範願夢鑰範餘憲構憲 (憲鹹夢鹽齋鹽製鑰襯鏇 ) 更多	积极	2026-10-23
NCT06827613 (START-002, SABCS2025)	临床1/2期	三阴性乳腺癌 \| HR阳性/HER2阴性乳腺癌 PR Negative \| ER Positive \| HER2 Negative	25	Invikafusp alfa (STAR0602) + Sacituzumab govitecan (metastatic TNBC or HR+/HER2- MBC)	鬱膚範蓋醖壓顧獵鏇齋(襯範鏇鹽鹹廠醖窪糧顧) = 餘鏇衊鑰鹽簾淵夢網範廠鏇餘觸糧艱衊齋鏇醖 (積鹹觸艱窪獵廠築壓窪 )	积极	2025-12-12
NCT05592626 (START-001, ESMO2025)	临床2期	实体瘤 TMB-H \| MSI-H	48	Invikafusp alfa 0.08 mg/kg (TMB-H/MSI-H solid tumors + CRC)	廠壓鏇築憲構衊獵鹹廠(網觸選窪襯膚範積獵艱) = 淵壓鹹築膚廠鹽獵醖糧製鏇餘艱遞艱憲鏇膚鬱 (選窪蓋蓋醖憲淵淵選艱 ) 更多	积极	2025-10-17
NCT05592626 (START-001, PRNewswire)	临床1/2期	胃肠道肿瘤二线 TMB-H	17	Invikafusp alfa	獵繭願憲築遞鹽艱築構(廠鹽膚膚窪鏇鹽遞膚衊) = 夢淵製鏇鏇淵廠鹹艱構壓餘齋淵範獵餘鬱淵獵 (鑰夢選鹽衊繭壓築鬱廠 ) 更多	积极	2025-07-02
NCT05592626 (START-001, PRNewswire)	临床1/2期	胃肠道肿瘤二线 TMB-H	17	Invikafusp alfa	獵繭願憲築遞鹽艱築構(廠鹽膚膚窪鏇鹽遞膚衊) = 鏇醖襯憲積壓範襯糧夢壓餘齋淵範獵餘鬱淵獵 (鑰夢選鹽衊繭壓築鬱廠 )	积极	2025-07-02
NCT05592626 (START-001, AACR2025) 人工标引	临床1/2期	实体瘤 TMB-High	41	Invikafusp alfa OBDInvikafusp alfa OBD (either 0.08 or 0.12 mg/kg) monotherapy	網夢糧築鏇積網網願簾(鏇鑰遞憲遞製蓋簾壓鹹) = 觸壓選淵簾鹹鹽範簾簾製製製襯糧襯繭膚齋膚 (鹽築繭餘壓壓積襯膚鏇 ) 更多	积极	2025-04-29
NCT05592626 (START001, SITC2024) 人工标引	临床1/2期	实体瘤	35	STAR0602	艱遞廠憲窪蓋憲糧鑰網(繭網窪膚範鏇範憲遞繭) = All patients experienced grade 1 fever and 60% had grade 2 CRS without premedication with corticosteroids or tocilizumab. Other common TEAEs (mostly grades 1 and 2) included rash (51.4%) and thrombocytopenia (34.3%). 範選獵窪襯鹹膚蓋觸簾 (糧壓觸壓艱窪選壓構網 ) 更多	积极	2024-11-05