A Phase 1B/2A Trial of NADUNOLIMAB in Combination With Azacitidine (With/Without Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem/progenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.

开始日期2025-01-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT05181462

/ Recruiting临床1/2期

A Randomized Non-comparative Open-label Phase 1b/2 Study of Nadunolimab in Combination with Gemcitabine Plus Carboplatin in Patients with Advanced Triple Negative Breast Cancer. "TRIFOUR Study"

Triple negative breast cancer (TNBC) represents approximately 15% of all breast cancers (BC) worldwide. The term triple negative means that tumor growth is not stimulated by the hormones estrogen and progesterone, nor by the HER2 protein, so unlike other types of BC, TNBC, which is an aggressive form of BC, does not have specific effective therapies available being the least common form of BC and the most difficult to treat.
Advanced or metastatic TNBC is treated with combinations of platinum-based chemotherapy with taxanes or gemcitabine with a 5-year survival rate of 12%. Recent studies have shown that TNBC expresses Interleukin 1 Receptor Accessory Protein (IL1RAP) at higher levels than other forms of BC.
Nadunolimab is a fully humanized monoclonal antibody that blocks the signals that occur within the cell produced by IL1RAP protein, thereby impairing the cancer cells' ability to secrete tumor stimulating substances, in turn reducing the tumor, inflammation and tumor progression. On the other hand, it is an antibody designed to activate the immune system to fight cancer cells.
This clinical trial is divided into two phases, phase Ib in which it is expected to include up to 15 patients and phase II in which it is expected to include 102 patients. The main purpose of phase Ib is to ensure that the combination of nadunolimab plus chemotherapy (gemcitabine plus carboplatin) is safe and determine the highest dose of nadunolimab that can be given safely without causing serious side effects. If the pre-specified objectives in this part are achieved, the trial will be expanded to a randomized phase II, to evaluate the efficacy of the combination of nadunolimab plus gemcitabine plus carboplatin, compared to a control group that will receive gemcitabine plus carboplatin only.

开始日期2022-01-11

申办/合作机构

Cantargia AB

[+1]

EUCTR2021-001695-42-ES

/ Unknown status临床1/2期

A Phase 1/2 study of CAN04, a fully humanised monoclonal antibody against IL1RAP, in combination with different chemotherapy regimens in subjects with advanced solid tumours

开始日期2021-09-22

申办/合作机构

Cantargia AB

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2024-12-02·CLINICAL CANCER RESEARCH

Efficacy and Safety of the Anti-IL1RAP Antibody Nadunolimab (CAN04) in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Advanced/Metastatic Pancreatic Cancer

Article

作者: Zvirbule, Zanete ; Awada, Ahmad ; Sanfridson, Annika ; Eefsen, Rikke L. ; Yachnin, Jeffrey ; Rydberg Millrud, Camilla ; Ochsenreither, Sebastian ; Magnusson, Susanne ; Tersago, Dominique ; Arnold, Dirk ; Collignon, Joelle ; Baltruskeviciene, Edita ; Garcia-Ribas, Ignacio ; Ivanauskas, Audrius ; Pfeiffer, Per ; Losic, Nedjad ; Van Cutsem, Eric

Abstract:

Purpose::

IL1 pathway upregulation is implicated in pancreatic ductal adenocarcinoma (PDAC) progression, therapy resistance, and survival. Nadunolimab is an IL1 receptor accessory protein (IL1RAP)–targeting antibody with enhanced antibody-dependent cellular cytotoxicity that blocks IL1α/IL1β signaling. We investigated efficacy and safety of nadunolimab in PDAC, in combination with gemcitabine/nab-paclitaxel (GN).

Patients and Methods::

Patients with previously untreated locally advanced/metastatic PDAC received nadunolimab (1.0–7.5 mg/kg) every 2 weeks with standard GN. The primary objective was safety; secondary objectives were antitumor response, progression-free survival, and overall survival (OS). Correlations between serum and tumor biomarkers and clinical response were explored.

Results::

Seventy-six patients were enrolled; the median age was 63 years (range, 43–89), 42% were female, 97% had metastatic disease, and 9% had received adjuvant chemotherapy. The most frequent grade ≥3 adverse event was neutropenia (66%), typically during cycle 1. Infusion-related reactions occurred in 29% (grade 3, 3%). Only 1 of the 76 patients had grade 3 or above peripheral neuropathy. No marked dose-dependent differences in safety or efficacy were observed among the four dose groups. The median OS was 13.2 months (95% confidence interval, 11.0–15.6), and the 1-year survival rate was 58%. The median immune PFS (immune Response Evaluation Criteria in Solid Tumours) was 7.1 months (95% confidence interval, 5.2–7.4). Treatment efficacy was higher in patients with high versus low tumor baseline IL1RAP expression (OS 14.2 vs. 10.6 months; P = 0.012). A reduction in serum IL8 on treatment correlated with prolonged OS.

Conclusions::

Nadunolimab combined with GN shows promising efficacy and manageable safety in locally advanced/metastatic PDAC. Higher tumor baseline IL1RAP expression correlated with better outcome.

2024-12-01·Journal for ImmunoTherapy of Cancer

Blocking IL1RAP on cancer-associated fibroblasts in pancreatic ductal adenocarcinoma suppresses IL-1-induced neutrophil recruitment

Article

作者: Hansen, Nils ; von Wachenfeldt, Karin ; Grönberg, Caitríona ; Liberg, David ; Millrud, Camilla Rydberg ; Peña-Martínez, Pablo ; Reinbach, Katrin ; Faria, Susanne Larsson ; Abdilleh, Kawther ; Järås, Marcus ; Skoog, Petter ; Hansen, Finja C ; Magnusson, Susanne

Background:

Pancreatic ductal adenocarcinoma (PDAC) represents a major clinical challenge due to its tumor microenvironment, which exhibits immune-suppressive properties that facilitate cancer progression, metastasis, and therapy resistance. Interleukin 1 (IL-1) signaling has been implicated as a driver in this process. Mechanistically, both IL-1α and IL-1β bind to the IL-1 receptor type 1, forming a complex with IL-1-receptor accessory protein (IL1RAP), which triggers downstream signaling pathways. The IL1RAP blocking antibody nadunolimab is currently in clinical development, but the precise consequences of inhibiting IL-1 signaling in PDAC remains elusive.

Methods:

To evaluate the biological relevance of blocking IL1RAP using nadunolimab in a PDAC animal model, human PDAC cells and cancer-associated fibroblasts (CAFs) were co-transplanted into mice. To study the underlying mechanisms of IL1RAP blockade ex vivo, co-cultured PDAC cells and CAFs were treated with nadunolimab prior to RNA sequencing. Migration assays were performed to assess how nadunolimab affects interactions between CAFs and myeloid immune cells. Finally, to establish a clinical correlation between IL1RAP expression and nadunolimab treatment effects, we analyzed tumor biopsies from a clinical phase I/II study in which nadunolimab was administered to patients.

Results:

In the xenograft mouse model, nadunolimab exhibited antitumor effects only when human CAFs were co-transplanted with PDAC cells. IL-1 stimulation induced CAFs to secrete chemokines that recruited neutrophils and monocytes. The secretion of this chemokine and the migration of myeloid cells were inhibited by nadunolimab. Media conditioned by IL-1-stimulated CAFs sustained a neutrophil population with a tissue invasion phenotype, an effect that was reversed by nadunolimab. In a cohort of metastatic late-stage PDAC patients receiving nadunolimab as monotherapy, high IL1RAP expression in tumors was associated with extended progression-free survival.

Conclusions:

Our study demonstrates that targeting IL1RAP on CAFs inhibits IL-1-induced chemokine secretion and recruitment of neutrophils and monocytes, thereby counteracting the immunosuppressive microenvironment in PDAC. These findings highlight the therapeutic potential of targeting IL1RAP in PDAC.

2023-03-01·Cancer immunology, immunotherapy : CII

Blockade of IL-1α and IL-1β signaling by the anti-IL1RAP antibody nadunolimab (CAN04) mediates synergistic anti-tumor efficacy with chemotherapy

Article

作者: Rydberg Millrud, Camilla ; von Wachenfeldt, Karin ; Deronic, Adnan ; Grönberg, Caitríona ; Liberg, David ; Forsberg, Göran ; Jaensson Gyllenbäck, Elin

IL-1α and IL-1β are both involved in several aspects of tumor biology, including tumor initiation, progression, metastasis, and not least in resistance to various therapies. IL-1α can function as an alarmin to signal cellular stress, and acts to induce downstream events, including production of IL-1β, to amplify the signal. Both IL-1α and IL-1β act through the same receptor complex, IL-1R1-IL1RAP, to mediate signal transduction. IL1RAP is expressed on tumor cells and in the tumor microenvironment by for example CAF, macrophages and endothelial cells. The anti-IL1RAP antibody nadunolimab (CAN04) inhibits both IL-1α and IL-1β signaling and induces ADCC of IL1RAP-expressing tumor cells. As both IL-1α and IL-1β mediate chemoresistance, the aim of this study was to explore the potential synergy between nadunolimab and chemotherapy. This was performed using the NSCLC PDX model LU2503 and the syngeneic MC38 model, in addition to in vitro cell line experiments. We show that chemotherapy induces expression and release of IL-1α from tumor cells and production of IL-1β-converting enzyme, ICE, in the tumor stroma. IL-1α is also demonstrated to act on stromal cells to further induce the secretion of IL-1β, an effect disrupted by nadunolimab. Nadunolimab, and its surrogate antibody, synergize with platinum-based as well as non-platinum-based chemotherapy to induce potent anti-tumor effects, while blockade of only IL-1β signaling by anti-IL-1β antibody does not achieve this effect. In conclusion, blockade of IL1RAP with nadunolimab reduces IL-1-induced chemoresistance of tumors.

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2024-12-18

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Cantargia Publishes Strong Preclinical Effects and Clinical Monotherapy Results on Nadunolimab in Pancreatic Cancer in Journal for Immunotherapy of Cancer

LUND, SE / ACCESSWIRE / December 18, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today announced the publication of preclinical and clinical results using the IL1RAP targeted antibody nadunolimab (CAN04) in pancreatic cancer (PDAC). Nadunolimab had pronounced effects on PDAC associated fibroblasts and inhibited recruitment of tumor promoting immune cells. These results were linked to monotherapy data in late-stage metastatic PDAC patients showing both clinically meaningful progression free survival and survival in patients with high IL1RAP levels. The studies were performed as a collaboration between Cantargia, Lund University and PanCAN."Nadunolimab's unique mechanism of action is highly relevant for treatment of pancreatic cancer. This important publication in an impactful scientific journal confirms its significance to the medical community" said Göran Forsberg, CEO of Cantargia.PDAC is one of the cancer forms with the highest medical need. The incidence is increasing, and the survival is poor. A major clinical challenge in PDAC is its distinct and protective tumor microenvironment (TME), which shields the tumor from the immune system and facilitates tumor growth, metastasis, and resistance to therapy. The crosstalk between cancer cells and cancer-associated fibroblasts (CAFs) plays a pivotal role in shaping this TME.The IL-1 family, through IL1RAP, helps activate CAFs, which attract myeloid immune cells like monocytes and neutrophils into the tumor. This study reveals that nadunolimab blocks this process by inhibiting IL1RAP, reducing the number of immune cells recruited, which weakens the tumor's defenses. Through its other mechanism of action (ADCC), nadunolimab enhances tumor destruction.The relevance of these preclinical results could be linked to clinical results using nadunolimab monotherapy in the CANFOUR study. In late stage metastatic PDAC patients, high tumor baseline levels of IL1RAP strongly correlate with increased progression free survival (IL1RAP high vs low: 3.5 vs 1.2 months; p=0.0023) and a trend for survival advantage (5.0 vs 2.2 months) with a follow up of 11.5 months. This is in line with previous published results examining nadunolimab with chemotherapies, gemcitabine and nab-paclitaxel, which showed promising efficacy in first line IL1RAP-high PDAC patients.These findings strongly signify the clinical relevance of targeting IL1RAP in PDAC using nadunolimab. This is particularly noteworthy since IL1RAP is considered as a prognostic marker where high IL1RAP expression is linked to shorter survival in PDAC patients."This study reveals how PDAC tumor cells and cancer-associated fibroblasts drive the immunosuppressive microenvironment through IL-1 signaling. It highlights IL1RAP targeting as a promising therapeutic approach for pancreatic cancer patients" said Dr Marcus Järås, corresponding author and Cantargia co-founder, from Lund University.This study used data from the Pancreatic Cancer Action Network's (PanCAN) Know Your Tumor® precision medicine program as a validation dataset, accessed through the PanCAN SPARK health data platform. This dataset was used to study the impact of IL1RAP expression in PDAC and revealed IL1RAP as a prognostic marker."These results underscore the importance of biomarker testing that allows patients to learn about the genetic makeup of their tumor and allow researchers access to treatment and outcomes data. Ongoing research using real-world datasets like from the Know Your Tumor program in the PanCAN SPARK platform brings researchers one step closer to better treatments and improved outcomes for patient with pancreatic cancer," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN.The article, titled "Blocking IL1RAP on cancer associated fibroblasts in pancreatic ductal adenocarcinoma suppresses IL-1 induced neutrophil recruitment", by Hansen et al., is available via Journal for Immunotherapy of Cancer website: https://jitc.bmj.com/ and at Cantargia's website https://cantargia.com. This publication is based on results that, in part, have been presented at scientific conferences during 2022 and 2023.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on hidradenitis suppurativa and systemic sclerosis.Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.About nadunolimab (CAN04)The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies). Positive data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462, also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine.AttachmentsCantargia publishes strong preclinical effects and clinical monotherapy results on nadunolimab in pancreatic cancer in Journal for Immunotherapy of CancerSOURCE: CantargiaRelated Documents:

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2024-12-11

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Cantargia and GEICAM Present Updated Phase 1 Clinical Data and New Translational Results on Nadunolimab Treatment in Advanced Triple Negative Breast Cancer at San Antonio Breast Cancer Symposium

LUND, SWEDEN / ACCESSWIRE / December 11, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm:CANTA) today reported updated results from the phase 1b study in 15 advanced triple negative breast cancer (aTNBC) patients treated with nadunolimab combined with platinum-based chemotherapy. The results confirm previous positive findings on safety, and promising antitumor activity. The clinical results along with new biomarker studies will be presented in a poster session at the upcoming San Antonio Breast Cancer Symposium (SABCS), 2024."Besides the strong clinical results already reported in pancreatic and lung cancers, we are excited to present these data in triple negative breast cancer. The presentation includes value-adding information around nadunolimab and its potential effects on the immune system's ability to counteract cancer progression," said Göran Forsberg, CEO of Cantargia.The TRIFOUR phase 1b part evaluated nadunolimab at 1 mg/kg (n=3) and 2.5 mg/kg (n=12) combined with gemcitabine and carboplatin (GC) in 15 previously treated aTNBC patients. Initial results were presented in 2023, and the updated results confirm an acceptable safety profile with a promising efficacy of 60% response rate, 6.2 months progression-free survival (PFS), and 12.8 months overall survival (OS).Analysis of patient samples was performed to identify features connected to nadunolimab/GC treatment. A significant reduction in the neutrophil to lymphocyte ratio (NLR) and C-reactive protein (CRP) was detected, both related to the nadunolimab mode of action. Additionally, a significant decrease in IL-8 levels was associated with a trend towards longer OS. These findings suggest that nadunolimab exerts beneficial effects on immune cells involved in tumor-promoting inflammation.Using a larger, separate set of pre-treatment tumor biopsies and blood samples, a characterization of IL1RAP expression was also performed. This analysis showed IL1RAP expression on tumor, stromal and tumor-infiltrating immune cells. Detailed analysis of circulating cells showed IL1RAP expression on myeloid cells, including myeloid-derived suppressor cells highlighting the relevance of IL1RAP as a promising target in aTNBC.The trial is currently enrolling patients for the randomized phase 2 part at the 2.5 mg/kg dose of nadunolimab with GC vs. only GC. Initial results for this part of the study are expected late H1 2025.The study is done in collaboration with GEICAM (Spanish Breast Cancer Research Group) and will be presented in a poster session at the 47th annual San Antonio Breast Cancer symposium (SABCS), Dec 10-13, 2024.More information on the poster session is found below:Poster number: SESS-3615Poster title: Updated safety, efficacy and emerging biomarker data from the Phase Ib part of a Phase Ib/II clinical study of nadunolimab in combination with gemcitabine and carboplatin in patients with advanced triple negative breast cancer (TRIFOUR study)Session date and time: December 11, 2024 (12:30 - 2:00 PM CST)The poster will be presented at the SABCS, 2024 in San-Antonio, Texas on Dec 11 from 12:30 - 2:00 PM local time by Dr Marta Santisteban Eslava, member of the GEICAM working group for triple negative disease, and one of the Chief Investigators of the TRIFOUR study. The poster related to the presentation will be uploaded on Cantargia's webpage www.cantargia.com.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on hidradenitis suppurativa and systemic sclerosis.Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.About nadunolimab (CAN04)The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316, evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies). Positive data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 40 NSCLC patients with median PFS of 7.2 months and a response rate of 55%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462, also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine.About GEICAMGEICAM is the leader group in breast cancer research in Spain with a recognized worldwide prestige. It is formed by more than 900 experts, who work in 200 institutions throughout Spain.Since its establishment in 1995 until now GEICAM has performed more than a hundred of studies in which almost 68,000 women and men have participated.It has a large multidisciplinary team specialized in the management of clinical trials and other studies, which collaborates with clinical researchers in the design and implementation of clinical trials, as well as in their execution and dissemination in forums and high-impact scientific journals.For more information, you can visit the official website http://www.geicam.org or follow GEICAM on Twitter @GEICAM, @GEICAMujer, and on Facebook.com/GEICAM.AttachmentsCantargia and GEICAM present updated phase 1 clinical data and new translational results on nadunolimab treatment in advanced triple negative breast cancer at San Antonio Breast Cancer SymposiumSOURCE: Cantargia

临床1期临床结果临床2期

2024-12-02

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Extraordinary General Meeting in Cantargia AB (publ)

LUND, SE / ACCESSWIRE / December 02, 2024 / Cantargia (STO:CANTA) Cantargia's extraordinary general meeting on December 2, 2024, resolved to approve the board's resolution from November 6, 2024 to increase the company's share capital through the issuance of new shares with pre-emptive rights for the company's shareholders. Subscription may also be made without pre-emptive rights, as set forth in the complete issue resolution.Through the rights issue, Cantargia's share capital will increase with not more than SEK 7,347,467.36, through the issue of not more than 91,843,342 new shares.The record date for the right to participate in the rights issue is December 4, 2024. Two existing shares held on the record date, entitle to subscription for one new share. The subscription price is SEK 1.85 per share.For further details and information about the background and reasons for the rights issue, see Cantargia's press release on November 6, 2024.For further information, please contactGöran Forsberg, CEOTelephone: +46 (0)46-275 62 60E-mail: [email protected]About CantargiaCantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on hidradenitis suppurativa and systemic sclerosis.Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com .AttachmentsExtraordinary general meeting in Cantargia AB (publ)SOURCE: Cantargia

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适应症	最高研发状态	国家/地区	公司	日期
胰腺癌	临床2期	美国	Cantargia AB	2024-02-20
晚期三阴性乳腺癌	临床2期	西班牙	Cantargia AB	2022-01-11
晚期恶性实体瘤	临床2期	法国	Cantargia AB	2021-09-22
晚期恶性实体瘤	临床2期	西班牙	Cantargia AB	2021-09-22
胆道癌	临床2期	法国	Cantargia AB	2021-09-22
胆道癌	临床2期	西班牙	Cantargia AB	2021-09-22
非小细胞肺癌	临床2期	法国	Cantargia AB	2021-09-22
结直肠癌	临床2期	奥地利	Cantargia AB	2017-09-19
结直肠癌	临床2期	比利时	Cantargia AB	2017-09-19
结直肠癌	临床2期	丹麦	Cantargia AB	2017-09-19

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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


NCT05181462 (TRIFOUR, SABCS2024 \| Company_Website) 人工标引	临床1/2期	晚期三阴性乳腺癌	15	Nadunolimab gemcitabine+ carboplatin	壓鑰構餘淵廠積鏇築壓(簾遞觸積艱簾壓鹽廠積) = 夢醖觸網鬱衊衊壓鬱廠鹹遞範齋膚蓋獵繭顧鏇 (積鬱觸觸襯簾鬱構鹽築, 32 ~ 84) 更多	积极	2024-12-10
NCT05116891 (CESTAFOUR, Company_Website) 人工标引	临床1/2期	肿瘤 \| 非小细胞肺癌 \| 胆道癌	-	Nadunolimab in combination with gemcitabine/cisplatin (NSCLC + first arm)	齋鑰築鹽衊繭鬱獵繭鬱(壓鏇膚觸製繭餘鏇遞蓋) = 艱夢廠艱餘鏇鏇觸淵膚鬱繭鏇顧艱築繭醖獵構 (願遞鬱鏇餘鹽願鹹艱築 ) 更多	积极	2024-10-28
				Nadunolimab in combination with gemcitabine/cisplatin (biliary tract cancer + first arm)	齋鑰築鹽衊繭鬱獵繭鬱(壓鏇膚觸製繭餘鏇遞蓋) = 憲選膚構繭觸簾鬱夢築鬱繭鏇顧艱築繭醖獵構 (願遞鬱鏇餘鹽願鹹艱築 ) 更多
NCT05116891 (CANFOUR, ESMO2024) 人工标引	临床1/2期	非小细胞肺癌一线 \| 二线	40	Nadunolimab cisplatingemcitabine	鏇範淵構衊衊廠襯憲鬱(鹹夢構憲壓繭獵夢願網) = 憲齋簾鏇鹹願鏇鹹獵襯顧窪獵糧鑰鏇壓鑰築顧 (觸築齋齋窪齋遞襯壓鏇 ) 更多	积极	2024-09-14
				Nadunolimab cisplatingemcitabine	鏇範淵構衊衊廠襯憲鬱(鹹夢構憲壓繭獵夢願網) = 獵鏇衊夢遞淵廠願獵廠顧窪獵糧鑰鏇壓鑰築顧 (觸築齋齋窪齋遞襯壓鏇 ) 更多
NCT04452214 (ESMO2024) 人工标引	临床1期	实体瘤 \| 头颈部鳞状细胞癌 \| 黑色素瘤 ... 二线更多	15	Nadunolimab 5 mg/kg + Pembrolizumab	襯壓顧糧繭觸簾製獵糧(積製齋壓選鹽選淵鹽簾) = 1(G3 febrile neutropenia) 齋鑰簾糧淵膚淵夢獵艱 (鏇積觸淵鏇襯遞積範鹽 ) 更多	积极	2024-09-14
NCT03267316 (CANFOUR, ASCO2024)	临床1/2期	胰腺癌	73	Nadunolimab 1 mg/kg	鑰獵齋獵衊繭窪鑰構蓋(鹹鏇鹹鹹鏇鏇鏇齋繭繭) = 鏇艱網網築構鏇鹹積網壓夢廠餘構憲醖築鑰壓 (鏇範醖衊淵製窪壓淵築 ) 更多	积极	2024-05-24
				Nadunolimab 2.5 mg/kg	鑰獵齋獵衊繭窪鑰構蓋(鹹鏇鹹鹹鏇鏇鏇齋繭繭) = 鹽壓膚襯鑰夢鹽壓醖鬱壓夢廠餘構憲醖築鑰壓 (鏇範醖衊淵製窪壓淵築 ) 更多
NCT05181462 (TRIFOUR, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	三阴性乳腺癌 HER2 Negative \| ER Negative \| PR Negative	13	nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 1 mg/kg)	壓遞蓋衊觸蓋膚築範膚(膚壓齋衊鹹憲鬱鑰糧廠) = 壓網憲艱蓋願構範衊膚鏇範醖獵襯觸鬱構簾衊 (餘遞艱鬱鬱夢蓋範鑰壓 )	积极	2023-10-21
				nadunolimab++gemcitabine 1000 mg/m2+carboplatin 2 mg/mL/min (Nadunolimab 2.5 mg/kg)	壓遞蓋衊觸蓋膚築範膚(膚壓齋衊鹹憲鬱鑰糧廠) = 製獵蓋淵淵遞網廠齋廠鏇範醖獵襯觸鬱構簾衊 (餘遞艱鬱鬱夢蓋範鑰壓 )
NCT03267316 (ASCO2023)	临床1/2期	非小细胞肺癌	30	Nadunolimab 1 mg/kg + cisplatin/gemcitabine	鹹構鏇觸獵繭鹽築觸艱(顧繭餘積鹹淵繭簾簾獵) = 築鑰築製糧艱憲淵觸築衊顧壓廠餘膚糧遞鏇獵 (夢範範鏇衊鏇觸製窪願, 3.7 ~ 7.5) 更多	积极	2023-05-31
				Nadunolimab 2.5 mg/kg + cisplatin/gemcitabine	積鬱繭夢選餘淵襯網膚(鹹繭鑰簾餘夢顧願醖窪) = 壓願鹽憲糧獵鬱餘繭鏇鹽夢憲顧鏇繭觸醖鏇鹹 (壓繭鹹鑰構鑰簾憲選簾 )
NCT03267316 \| NCT05116891 (CANFOUR, AACR2023)	临床1/2期	胰腺导管腺癌	73	Nadunolimab	鹹鹹餘選廠餘築艱顧觸(鏇繭憲衊鑰壓積窪憲觸) = 鹹餘觸淵範醖衊願廠壓鏇觸製選蓋齋觸構觸齋 (鹹蓋襯獵鑰衊膚淵獵網, 10.0 ~ 19.1) 更多	-	2023-04-04
NCT03267316 (CANFOUR, ASCO2022) 人工标引	临床1/2期	胰腺腺癌	76	gemcitabine+nab-paclitaxel+nadunolimab	膚窪顧糧繭鏇選夢願鹹(蓋構積築願觸鹽網襯製) = Infusion-related reactions were reported in 29% (grade 3 in 3%). Peripheral sensory neuropathy was rare (only two grade 2 events). 艱糧遞齋醖選鏇願餘醖 (獵鬱憲網壓艱構顧鹹艱 ) 更多	积极	2022-06-02
NCT03267316 (CANFOUR, ASCO2022) 人工标引	临床1/2期	非小细胞肺癌	33	gemcitabine+Cisplatin+nadunolimab	窪顧觸製鑰繭蓋鑰網齋(蓋憲積餘憲壓蓋憲夢衊) = 膚網艱餘窪選膚範夢窪襯齋餘憲構窪鹽齋鑰膚 (範壓醖鹽夢窪襯憲襯獵 ) 更多	积极	2022-06-02
				gemcitabine+Cisplatin+nadunolimab	襯糧顧鬱廠壓觸憲鏇窪(鹹憲選鑰膚鑰糧觸簾遞) = 齋選憲鏇淵壓壓蓋築壓醖積憲築糧築鏇觸繭構 (鹹構夢夢餘範製艱夢製 )