[M25-632]A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination with Budigalimab(ABBV-181) in Adult Subjects with Advanced Squamous Tumors

开始日期2025-12-17

申办/合作机构

AbbVie GK

NCT07241039

/ Recruiting临床1期

A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-711 as a Monotherapy or in Combination With Budigalimab (ABBV-181) in Adult Subjects With Advanced Squamous Tumors

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-711 as a monotherapy and in combination with budigalimab (ABBV-181) in adults with advanced squamous tumors.
ABBV-711 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-711 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 220 adult participants will be enrolled in the study across 40 sites worldwide.
In part 1, oral ABBV-711 tablets will be given in escalating doses alone to participants with squamous (sq) tumors. In part 2 oral ABBV-711 tablets will be given at a selected dose from part 1 to participants with squamous non-small cell lung cancer (sqNSCLC), or head and neck squamous cell carcinoma (HNSCC). In part 3, oral ABBV-711 tablets will be given in escalating doses in combination with intravenously (IV) infused budigalimab to participants with sq tumors. In part 4 oral ABBV-711 tablets will be given at a selected dose from part 3 in combination with IV infused budigalimab to participants with sqNSCLC, or HNSCC. The estimated duration of the study is up to approximately 5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent questionnaire, medical assessments, blood tests, and scans.

开始日期2025-11-20

申办/合作机构

AbbVie, Inc.

NCT06772623

/ Recruiting临床1/2期

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.
In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

开始日期2025-03-06

申办/合作机构

AbbVie, Inc.

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项与布格利单抗相关的文献（医药）

2026-04-01·Journal for ImmunoTherapy of Cancer

Phase 1b study of ABBV-368, tilsotolimod, budigalimab, and nab-paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma

Article

作者: Ramathal, Cyril ; Blaney, Martha ; Le, Xiuning ; Ochsenreither, Sebastian ; Haderlein, Marlen ; Daste, Amaury ; Oliva, Marc ; Perets, Ruth ; McDevitt, Michael ; Patel, Maulik ; Hong, Jaehyung ; Le Tourneau, Christophe ; Popovtzer, Aron ; Sukari, Ammar ; Rosenberg, Ari J ; Makkouk, Amani

Background:

ABBV-368 is a humanized monoclonal antibody that targets the costimulatory receptor OX40. Here, we investigate a treatment strategy with ABBV-368 combined with the investigational toll-like receptor 9 agonist tilsotolimod, the programmed cell death 1 inhibitor budigalimab, and nab-paclitaxel in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). To our knowledge, this is the first clinical study in this setting to investigate chemotherapy combined with three immunotherapy agents, aiming to overcome failure of prior immune checkpoint inhibition and chemotherapy.

Methods:

This phase 1b, multicenter, open-label study ( NCT04196283 ) enrolled adult patients with R/M HNSCC into one of three treatment arms: ABBV-368 with tilsotolimod, ABBV-368 with tilsotolimod and nab-paclitaxel, or ABBV-368 with tilsotolimod, nab-paclitaxel, and budigalimab. Patients were treated in 28-day cycles. ABBV-368, nab-paclitaxel, and budigalimab were administered intravenously and tilsotolimod via intratumoral injection. Study objectives included safety, tolerability, pharmacokinetics, and preliminary antitumor activity. In addition, biomarker analyses were performed.

Results:

Overall, 30 patients were enrolled; 16 received ABBV-368 plus tilsotolimod, 7 ABBV-368 plus tilsotolimod and nab-paclitaxel, and 7 ABBV-368 plus tilsotolimod, nab-paclitaxel, and budigalimab. In total, 80% of patients experienced any-grade adverse events related to ABBV-368. ABBV-368 and tilsotolimod induced peripheral interferon-gamma pathway upregulation, Th1 cytokine production, and T-cell activation that was not negatively impacted by nab-paclitaxel. There were no responses in the ABBV-368 plus tilsotolimod arm; one partial response was demonstrated in both the ABBV-368 plus tilsotolimod and nab-paclitaxel, and ABBV-368 plus tilsotolimod, nab-paclitaxel, and budigalimab arms, corresponding to an overall response rate of 14.3%.

Conclusions:

The quadruple combination of ABBV-368, tilsotolimod, nab-paclitaxel, and budigalimab was well tolerated and demonstrated pharmacodynamic activity. Several patients had disease stabilization, but clinical responses were limited. Initial priming and T-cell immune activation were inadequate to overcome prior therapy resistance mechanisms including a hypothesized unfavorable tumor microenvironment. Future work investigating strategies to target this inhibitory tumor microenvironment with optimally scheduled immunotherapy combinations in selected patients and indications is urgently needed to improve patient outcomes.

Trial registration number:

NCT04196283 .

2026-01-01·Contemporary Clinical Trials

Analytical treatment interruption as a tool in the evaluation of immune-mediated interventions for long-term antiretroviral-free control of HIV-1 among people with HIV

Article

作者: Topp, Andrew ; Abunimeh, Manal ; Pires Dos Santos, Ana Gabriela ; Berry, Jeff ; Lalezari, Jacob P ; Dubé, Karine ; Gill, Sarah ; Routy, Jean-Pierre ; Diaz, Ricardo Sobhie ; Sokhela, Simiso M ; Cohen, Daniel ; Mothe, Beatriz ; Schwarze, Siegfried ; Lewin, Sharon R ; Krishnan, Preethi ; Sinclair, Gary I

BACKGROUND:

Immune-mediated interventions have the potential to induce long-term antiretroviral treatment (ART)-free viral suppression in people with HIV. However, in the absence of biomarkers of viral control, studies looking at immune interventions require a planned long-term analytical treatment interruption (ATI) that may bring risks to participants and challenges for data interpretation. Herein, we describe an ongoing, global, proof-of-concept, randomized, placebo-controlled, phase 2 clinical trial with a planned ATI and illustrate how those risks have been mitigated to safely evaluate the long-term durability of ART-free viral control.

METHODS:

The trial evaluates an immunologic combination of low-dose budigalimab and trosunilimab administered during ATI. Adults aged 18-70 with confirmed HIV-1 on stable ART with viremia below the limit of detection and CD4+ counts >500 cells/mL willing to undergo ATI are randomized to receive budigalimab, trosunilimab, both (at 2 different trosunilimab doses), or neither. The primary efficacy endpoint is the proportion of participants achieving viral control (HIV-1 RNA <1000 copies/mL) without restarting ART at week 24. The planned ATI duration (≤112 weeks) evaluates the durability of off-ART viral control, long-term safety, and biomarkers. Key ATI elements align with published consensus recommendations [1] while incorporating feedback from members of the global HIV community.

CONCLUSIONS:

By sharing this study design, we hope to inform on the lessons learned from operationalizing a global study evaluating durable ART-free viral control, including the critical role of engaging members of the HIV community during clinical trial design to ensure the success of an ATI-inclusive study.

2025-11-01·NATURE MEDICINE

Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study

Article

作者: Felizarta, Franco ; Lalezari, Jacob P ; Ramgopal, Moti N ; Betman, Heide ; Alcaide, Maria L ; Pires Dos Santos, Ana Gabriela ; Zhou, Fei ; Vaidya, Tanaya R ; Krishnan, Preethi ; Dorr, Patrick ; Routy, Jean-Pierre ; Mostafa, Nael M

Abstract:

Chronic human immunodeficiency virus type 1 (HIV-1) disease results in immune exhaustion and dampened T cell responses, and programmed cell death 1 (PD-1) inhibitors offer a potential approach to enable viral control without antiretroviral therapy (ART) through reversal of these effects. Budigalimab is an investigational humanized anti–PD-1 monoclonal antibody. Multiple intravenous (IV) low doses of budigalimab (Stage 1: 2 mg n = 10, 10 mg n = 10, placebo n = 5, two doses every 4 weeks; Stage 2: 10 mg n = 11, placebo n = 5, four doses every 2 weeks (Q2W)) were assessed in people living with HIV (PLWH; n = 41) in a randomized, double-blind, multicenter, placebo-controlled phase 1 study with an analytical treatment interruption (ATI) to identify an efficacious regimen with a favorable safety profile in PLWH. The primary endpoints were safety, tolerability and pharmacokinetics. Demographics and baseline characteristics were balanced across treatment groups, except for sex, which was mostly male. All participants identified as cisgender. Budigalimab was well tolerated for up to 44 weeks, with 29 of 41 participants experiencing an adverse event (AE), including 2 participants who each experienced one grade 1 reversible immune-related AE (thyroiditis, hyperthyroidism). Three grade 3 AEs were reported by two participants and one serious AE by one participant; none were deemed related to treatment. IV budigalimab 10 mg Q2W resulted in a slight accumulation of drug in serum, with concentrations remaining above the estimated concentration required for near-complete (>95%) PD-1 receptor saturation on CD8 + T cells for ~10 weeks in peripheral blood. In an exploratory efficacy analysis of a 12-week ATI initiated with the first of four 10 mg Q2W doses, 6 of 11 participants experienced a delayed rebound with a relatively low viral peak and/or off-ART viral control (<200 copies ml −1 ) for ≥6 weeks during ATI, with 2 sustaining ART-free viral control to study end (204−252 days). The study achieved prespecified endpoints, supporting further evaluation of budigalimab in PLWH in a phase 2 study. ClinicalTrials.gov identifier: NCT04223804 .

项与布格利单抗相关的新闻（医药）

2026-08-21

·PRNewswire

AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline

Clinical data from AbbVie's ABBV-1480 (RC148) PD-1/VEGF bispecific antibody in the frontline non-small cell lung cancer (NSCLC) setting will be presented via an oral presentation Additionally, new data and updates from AbbVie's telisotuzumab adizutecan (Temab-A) and ABBV-706 programs across NSCLC and small cell lung cancer (SCLC) to be shared Research reflects AbbVie's strategy aimed at building a lung cancer pipeline spanning next-generation immunotherapies, targeted antibody-drug conjugates (ADCs) and the potential for novel combination approaches NORTH CHICAGO, Ill., Aug. 21, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data highlighting research programs across its lung cancer portfolio being presented at the 2026 World Conference on Lung Cancer (WCLC), including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). The presentations span clinical, translational and real-world data across next-generation immunotherapies and targeted antibody-drug conjugates (ADCs), designed to generate insights into treatment burden, patient experience and biomarker identification that may help inform future research. "Our strategy in lung cancer is focused on building a complementary pipeline that brings together next-generation immunotherapies and targeted antibody-drug conjugates with the potential to address different aspects of tumor biology," said Daejin Abidoye, M.D., vice president and therapeutic area head of oncology, solid tumor and hematology at AbbVie. "Exploring the PD-1/VEGF approach represented by ABBV-1480 and the c-Met targeting by Temab-A are important elements of that strategy and may provide a foundation for potential novel combinations as we work to develop more tailored treatment approaches for people living with lung cancer." Advancing Novel Therapies Across Various Modalities in NSCLC Multiple presentations across AbbVie's NSCLC portfolio will showcase new studies and data analyses spanning multiple treatment modalities, highlighting first-line treatment approaches, patient experience and biomarker-informed research. ABBV-1480 (RC148): AbbVie, in partnership with RemeGen, will present Phase 1b data evaluating the investigational PD-1/VEGF bispecific antibody, ABBV-1480, in combination with platinum-based chemotherapy as a potential first-line treatment for advanced NSCLC. At the 10 mg/kg dose, identified as the recommended Phase 3 dose for further development in combination regimens in both squamous and non-squamous NSCLC, the primary endpoint of objective response rate (ORR) was 90.0% in squamous NSCLC (n=27/30) and 75.9% (n=22/29) in non-squamous NSCLC. The most common treatment-related adverse events (TRAEs) were a decrease in white blood cells, neutrophil, platelet counts and anemia. No grade ≥3 hemorrhages with the 10 mg combinations were observed. This overall manageable safety profile supports ongoing Phase 3 development for this novel investigational asset.1 Telisotuzumab adizutecan (Temab-A), an investigational c-Met-directed ADC with a topoisomerase 1 inhibitor (Top1i) payload: Building on encouraging preliminary activity2 observed in heavily pretreated patients, AbbVie initiated a Phase 1b/2 M24-536 study (NCT06772623). The study is evaluating a platinum-free combination of Temab-A and a PD-1 inhibitor, as a potential first-line treatment for advanced non-squamous NSCLC. The study includes analyses of c-Met and PD-L1 expression to identify the patients most likely to benefit from treatment.3 Temab-A is also being studied in epidermal growth factor receptor (EGFR)-mutated NSCLC as monotherapy or in combination with osimertinib (NCT07155187). Clinical Data Showcasing the Potential of ABBV-706 in SCLC ABBV-706 is an investigational SEZ6-targeted ADC with a Top1i payload, being evaluated in SCLC. Presentations at WCLC include research that further characterizes the program and the potential role of SEZ6 in SCLC. As previously reported, ABBV-706 demonstrated an ORR of 82% in patients with relapsed/refractory SCLC post platinum-based chemotherapy (n=17).4 New safety analyses from 240 patients who received ABBV-706 monotherapy showed generally manageable hematologic and gastrointestinal toxicities, with the most common gastrointestinal events, including nausea (35.8%), vomiting (17.5%) and diarrhea (10.8%), being largely low grade and most requiring no dose adjustments.5 Grade ≥3 treatment-related pneumonitis or interstitial lung disease was reported in 1.7% of patients receiving ABBV-706 monotherapy.6 Hematologic toxicities, including anemia, neutropenia and thrombocytopenia, were among the most common TRAEs.5 Serious TRAEs occurred in 12.5% of patients. ABBV-706 is being evaluated as monotherapy in a Phase 3 study (NCT07365241) and in combination with atezolizumab in the Phase 2 study (NCT07155174), in SCLC. Real-world research demonstrated that SEZ6 is broadly expressed in 91% of SCLC patients overall and in more than 96% of patients with brain or liver metastases. These findings further support SEZ6 as a potential therapeutic target in SCLC and other SEZ6-expressing tumors. 7 Additional details on key presentations are available below, and the full WCLC 2026 abstracts are available online. For information about AbbVie's clinical trial efforts in lung cancer, please visit clinicaltrials.gov. Telisotuzumab adizutecan (Temab-A) and ABBV-706 are investigational medicines and are not approved by any health authorities worldwide. The safety and efficacy of these investigational medicines are under evaluation as part of ongoing clinical studies. AbbVie holds exclusive rights from RemeGen to develop, manufacture, and commercialize ABBV-1480 outside of the Greater China territory. Emrelis™ (telisotuzumab vedotin-tllv) is an approved medicine being investigated for additional uses. Safety and efficacy have not been established for these unapproved additional uses. U.S. Prescribing Information for AbbVie Medicines Please see full Prescribing Information for EMRELIS™ (telisotuzumab vedotin-tllv). About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. About AbbVie in Oncology  AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.  Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit .  Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: Zhang L, Zhao Y, Fan Y, et al. RC148 (ABBV-1480, PD-1/VEGF bispecific antibody) plus chemotherapy in first-line locally advanced or metastatic non-small cell lung cancer. Abstract OA14.01.03. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. De Miguel M, Yamamoto N, Raimbourg J, et al. ABBV-400, a c-Met protein-targeting antibody-drug conjugate (ADC), in patients with advanced EGFR wild-type non-squamous non-small cell lung cancer: results from a phase I study. Ann Oncol. 2024;35(Suppl):S805-S806. Abstract 1257MO. Horinouchi H, Cuppens K, Camidge DR, et al. Telisotuzumab adizutecan and PD-1 inhibitor in untreated advanced non-squamous non-small cell lung cancer: a phase 1b/2 study. Abstract P2.374. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Byers LA, Cho BC, Cooper AJ, et al. ABBV-706 as monotherapy and in combination with budigalimab in patients with relapsed/refractory (R/R) small cell lung cancer (SCLC). J Clin Oncol 44, 8008-8008 (2026). Chiang AC, Byers LA, Cooper AJ, et al. Hematologic and Gastrointestinal Toxicity of ABBV-706 in Advanced Solid Tumors: Safety Profile from the First-in-Human Study. Abstract P3.316. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Paz-Ares L, Chandana S, Chiang AC, et al. Pneumonitis/Interstitial Lung Disease in the First-in-Human ABBV-706 Study: Incidence, Management, and Risk Factors. E-Poster EP13.32. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. Jahchan N, Calip GS, Guadamuz JS, et al. SEZ6 is expressed across major clinical and demographic groups of SCLC patients: evidence from a US clinicogenomic database. Abstract P3.340. presented at the World Conference on Lung Cancer, 2026. Seoul, Republic of Korea. SOURCE AbbVie 21% more press release views with Request a Demo

临床结果临床1期抗体药物偶联物免疫疗法临床3期

2026-08-04

·BioPlus

2026 Q2管线调整：6家MNC，有哪些重大变化？

01 AbbVie AbbVie Q2管线更新，仅1项终止，anti-GARP/TGFβ1 complex单抗livmoniplimab退出NSCLC：靶向GARP–TGF-β1复合物的单抗livmoniplimab退出非小细胞肺癌（NSCLC）开发。其Ⅱ/Ⅲ期LIVIGNO-4研究原计划在一线转移性非鳞NSCLC中，比较livmoniplimab联合PD-1抗体budigalimab及化疗与pembrolizumab联合化疗；AbbVie未披露终止原因。此前中国临床CTR20242998（一项在局部晚期或转移性肝细胞癌 (HCC) 中国成人受试者中评价静脉注射 Livmoniplimab 联合 Budigalimab 的不良事件及体内移动情况研究）披露主动终止，终止的原因报道为基于战略考量。 Q2共列出4款项目进入Ⅰ期： IL-13×IL-31R双特异性抗体ABBV-313用于特应性皮炎， CD19项目ABBV-519用于类风湿关节炎和系统性红斑狼疮口服IL-23R抑制剂ABBV-859用于银屑病长效IL-1α×IL-1β双特异性抗体ABBV-1451用于化脓性汗腺炎。另外，拟收购Apogee带来的zumilokibart（anti-IL-13单抗）、APG279（anti-IL-13单抗+anti-OX40L单抗）和APG333（anti-TSLP单抗）已被预先列入管线图，但交易预计在Q3完成。 02 GSK GSK在2026年Q2只有2款项目研发终止： nivisnebart（AL101/GSK4527226）是一款由Alector与GSK共同开发、靶向分选蛋白1（sortilin，SORT1）的单抗，通过下调sortilin提高脑内颗粒蛋白前体（progranulin，PGRN）水平。其用于早期阿尔茨海默病的Ⅱ期PROGRESS-AD研究（NCT06079190）纳入367例患者。预设中期无效性分析显示，该研究不太可能达到减缓疾病进展的主要终点，项目因此终止。 GSK3923868是一款吸入PI4Kβ抑制剂，拟用于人鼻病毒感染，GSK已将其状态更新为“终止开发”；GSK未披露停止推进的具体依据。 03 BMS BMS在2026年Q2终止3款项目，包括两款Ⅰ期资产和一款Ⅲ期资产，分别为CEACAM5–TOP1i ADC BMS-986490、真核翻译起始因子2B（eIF2B）激活剂comtifator，以及雄激素受体（AR）配体导向降解剂BMS-986365： BMS-986490靶向癌胚抗原相关细胞黏附分子5（CEACAM5），采用拓扑异构酶Ⅰ抑制剂（TOP1i）载荷，此前在CEACAM5表达的晚期实体瘤中开展Ⅰ/Ⅱa期研究，BMS未披露具体终止原因。 Comtifator（BMS-986419/EVT8683）来自Evotec合作，拟通过激活eIF2B调节整合应激反应（ISR），BMS将其终止归因于管线组合评估。 BMS-986365兼具AR降解和拮抗作用，用于转移性去势抵抗性前列腺癌（mCRPC）。Ⅲ期rechARge研究Part 1分析显示，项目在Part 2达到预设疗效目标的概率较低，BMS因此终止开发。另一款AR降解剂BMS-986460仍处于Ⅰ期，说明公司并未退出AR降解方向。 Q2另有2款项目新增至Ⅰ期管线：机制尚未披露的神经退行性疾病项目BMS-986533 用于自身免疫病的CD19体内CAR-T OTX-201。OTX-201通过靶向脂质纳米颗粒递送编码CD19 CAR的环状RNA，在体内生成CAR-T细胞。 04 Sanofi Sanofi在2026年Q2集中收缩免疫管线。IL-33抗体itepekimab因COPDⅢ期结果不一致，并在慢性鼻窦炎中未达到内部疗效预期，整体临床开发终止；口服TNFR1信号抑制剂balinatunfib因克罗恩病和溃疡性结肠炎Ⅱ期中期结果未达预期而停止开发；同时抑制MMP13和ADAMTS5的软骨锚定型Nanobody SAR446959，也因获益–风险评估不支持继续推进而终止。此外，OX40L抗体amlitelimab退出特应性皮炎开发，Dupixent、riliprubart和venglustat也分别有部分适应症停止，但相关分子仍在其他适应症推进。 Q2另有两款新药进入Ⅰ期：第二代IRAK4降解剂SAR447971（KT-485）和pan-KRAS抑制剂SAR449336（BLU-924），详细信息见Sanofi Q2管线大调整：多项免疫终止，2款新药进入Ⅰ期。 05 Roche Roche在2026年Q2从开发管线中移出7款新分子实体（NME），包括4款I期和3款II期项目： I期项目中，CD19×CD3 T细胞衔接器（TCE）RG6382因现有数据未显示出继续推进系统性红斑狼疮（SLE）的必要分子特征而终止； SNP选择性HTT反义寡核苷酸（ASO）RG6496则因平行动物研究显示不支持长期重复给药而停止开发。 BRAF抑制剂mosperafenib（RG6344）的I期数据被Roche评价为积极，但公司决定停止内部推进并寻求对外授权；作用机制尚未披露的实体瘤项目RG6468也在评估I期数据后终止。 II期项目中，HTT ASO tominersen（RG6042）未达到亨廷顿病（HD）研究的疗效目标，尽管实现了HTT降低并达到安全性和生物标志物终点，仍未改善疾病严重程度。 Tie2激动剂RG6351用于糖尿病黄斑水肿（DME），Roche认为其超越Vabysmo的可能性较低，因此停止推进。 GLP-1/GIP双受体激动剂acmopatide（RG6641/CT-868）虽然取得阳性II期结果，但因1型糖尿病（T1D）管线优先级调整而终止，Roche将资源转向enicepatide。此外，NLRP3抑制剂selnoflast（RG6418）的I期炎症适应症被移出，但其冠状动脉疾病项目同步进入II期，因此并非分子整体终止。 06 AstraZeneca AstraZeneca在2026年Q2从开发管线中移出4款新分子实体（NME），包括2款Ⅰ期和2款Ⅱ期项目；另有1项Ⅲ期联合治疗研究停止推进： Ⅰ期项目中，AZD2068（原FPI-2068）是一款靶向EGFR/cMET的锕-225放射性偶联药物，用于晚期实体瘤，其Ⅰ期研究因PK/PD终止。 AZD4360是一款CLDN18.2 TOP1i ADC，Ⅰ/Ⅱ期CONCLUDE研究覆盖胰腺导管腺癌、胃/胃食管结合部癌和胆道癌，因疗效终止（详细信息见AZ两款ADC退出管线：一款因疗效，一款因PK/PD?）。 Ⅱ期项目中，吸入式JAK1抑制剂AZD4604用于中重度哮喘，其两项Ⅱa期研究AJAX和ARTEMISIA均因疗效终止。 tilatamig samrotecan（AZD9592）是一款EGFR×cMET双特异性TOP1i ADC，其EGRET研究因PK/PD终止。此外，PD-L1抗体Imfinzi（durvalumab）联合TIGIT抗体domvanalimab用于同步放化疗后不可切除Ⅲ期非小细胞肺癌的Ⅲ期PACIFIC-8研究，因战略性管线优先级调整而终止。 Q2另有2款NME进入Ⅰ期：作用机制尚未披露的呼吸领域项目AZD4916已在健康志愿者中启动研究；STEAP2靶向T细胞衔接器AZD8359（TITAN TCE）则进入前列腺癌Ⅰ/Ⅱ期CRIUS-1研究。欢迎大家加入BioPlus Partners微信交流群。入群申请联系人：Lisa 邮箱：lisa.li@bp-bioplus.com 电话：18662346610（同微信）入群申请，请先添加Lisa微信，并分享名片入群画像：Biotech/药厂研发/BD、投资机构、临床医生等入群福利：不定时行业资料包分享

2026-07-25

·药弈

CD39靶点（下）：联合策略、生物标志物与成药前景

在上篇中，我们系统梳理了CD39的生物学特性、全球管线和核心临床数据。我们看到，CD39作为腺苷通路的上游闸门，具有独特的双重作用机制，但也面临单药疗效有限、通路冗余等挑战。下篇中，我们将聚焦三个核心问题：CD39抑制剂应该和什么联用？如何筛选获益患者？这一靶点的长期成药前景如何？六、联合治疗策略：从"单打独斗"到协同作战 CD39抑制剂单药疗效有限已经成为行业共识。联合用药是CD39靶点走向临床应用的必由之路。目前，研发领域正在探索多种联合策略，各有其理论基础和临床证据。6.1 联合化疗：最成熟的组合化疗药物不仅能直接杀伤肿瘤细胞，更重要的是能诱导免疫原性细胞死亡（ICD），释放ATP、HMGB1、钙网蛋白等危险信号，激活先天免疫和适应性免疫。然而，化疗释放的ATP会被CD39迅速代谢为腺苷，反而可能削弱化疗的免疫激活效应。因此，CD39抑制剂与化疗的联合，相当于为化疗"保驾护航"，让ATP充分发挥免疫刺激作用。这一策略已经在临床上得到了初步验证：TTX-030联合budigalimab（抗PD-1）+ FOLFOX化疗在胃癌/胃食管结合部癌中ORR达52.5%，DCR达92.5%TTX-030联合吉西他滨/nab-紫杉醇在转移性胰腺癌中ORR达30%，中位OS达19.1个月，HLA-DQ高表达亚组ORR达46%IPH5201联合度伐利尤单抗+化疗的MATISSE II期研究在可切除NSCLC新辅助治疗中取得27.5%的pCR率从作用机制上，不同化疗药物诱导ICD的能力不同。奥沙利铂、阿糖胞苷、紫杉醇等被认为是较强的ICD诱导剂，与CD39抑制剂的协同效应可能更显著。6.2 联合免疫检查点抑制剂：最自然的搭档 CD39-腺苷通路是肿瘤免疫抑制的重要机制之一，也是PD-1/PD-L1抑制剂耐药的潜在原因。因此，CD39抑制剂与ICB的联合是逻辑上最自然的组合。临床前研究广泛证实了这一协同效应：在多种肿瘤模型中，CD39抑制剂与抗PD-1/PD-L1抗体联用，均能显著增强抗肿瘤免疫应答，包括ICB耐药模型中也能观察到疗效提升。不过，CD39抑制剂与ICB的联合疗效在不同临床场景中表现不一。在晚期实体瘤的I期研究中，IPH5201联合度伐利尤单抗未观察到客观缓解，疗效信号有限，这可能与入组患者多线治疗后的肿瘤免疫抑制状态有关。但在新辅助治疗场景下，IPH5201联合度伐利尤单抗+化疗的MATISSE II期研究取得了积极结果：在40例可切除NSCLC患者的中期分析中，总体pCR率达27.5%，PD-L1≥1%亚组pCR率达35.7%，PD-L1≥50%亚组更是高达50%。这提示CD39抑制剂在肿瘤微环境相对完整的早期患者中可能更具价值。目前MATISSE研究仍在继续招募PD-L1≥1%的患者以进一步富集数据。目前，多项CD39抑制剂+PD-1/PD-L1抑制剂的联合研究正在进行中，包括TTX-030等均在开展相关研究。SRF617的II期联合研究已终止，反映了CD39靶点临床转化的曲折性。6.3 联合CD73抑制剂：双靶点阻断的协同同时阻断CD39和CD73，理论上能更彻底地抑制腺苷生成通路。这种上下游双靶点联合有几个潜在优势：更全面的通路阻断：CD39抑制减少AMP生成，CD73抑制阻止AMP向腺苷转化，两者协同更彻底覆盖不同空间区域：CD39主要在基质区，CD73在肿瘤实质和基质均有表达，联合可覆盖更广保留ATP+阻断腺苷：CD39抑制保留ATP免疫刺激，CD73抑制阻断腺苷免疫抑制，双重获益临床前研究显示，CD39/CD73双靶点联合确实能更显著地恢复T细胞功能，增强抗肿瘤免疫。目前，这一策略的临床转化正在推进中，包括双特异性抗体可能是更优的给药方式。6.4 联合放疗：远隔效应的放大器放疗不仅能直接杀伤肿瘤细胞，还能诱导免疫原性细胞死亡，释放ATP和肿瘤抗原，激活抗肿瘤免疫。同时，放疗也会诱导CD39和CD73的表达上调，导致腺苷积累，抑制放疗后的免疫应答。 CD39抑制剂与放疗联合，理论上能增强放疗的免疫激活效应，促进远隔效应（abscopal effect）的发生。临床前研究已经观察到了这一协同效应，但临床验证尚在早期。6.5 双抗策略：一石二鸟的创新除了两个单抗联合，双特异性抗体也是CD39领域的重要创新方向。双抗策略有望通过更精准的靶向递送和协同作用机制，克服单靶点的局限性。目前在研的CD39双抗主要有几类：双抗类型代表药物研发阶段优势CD39/TGF-βES014（科望）II期同时阻断腺苷和TGF-β两大免疫抑制通路CD39/CD73HB0046（华奥泰）等I期上下游双靶点阻断，更彻底抑制腺苷生成CD39/PD-L1多个在研临床前同时靶向免疫抑制通路+免疫检查点其中，CD39/TGF-β双抗ES014的临床数据最为亮眼，在硬纤维瘤中取得40%的ORR。这也验证了双抗策略的潜力——通过同时阻断两条非冗余的免疫抑制通路，有望实现1+1>2的协同效应。 CD39/CD73双抗则代表了另一种思路——通过同时阻断腺苷生成通路的上下游两个关键酶，理论上能更彻底地抑制胞外腺苷的积累。临床前研究显示，CD39/CD73双抗在多种肿瘤模型中展现出优于单靶点抗体的抗肿瘤活性。全球已有多家企业布局这一方向，其中华奥泰生物的HB0046是全球首个进入临床阶段的CD39/CD73双特异性抗体，于2024年7月获NMPA批准开展临床试验。HB0046采用抗CD39的VHH（重链可变区）片段与抗CD73单抗连接的双抗设计，能够同时抑制膜结合型和可溶型CD39与CD73的酶活，在临床前研究中显示出良好的安全性和抗肿瘤活性。 CD39/PD-L1双抗则尝试将腺苷通路抑制与免疫检查点阻断合二为一，有望简化联合用药方案，提高患者依从性。不过这类双抗的临床价值仍需验证——毕竟CD39单抗与PD-1单抗的自由联合方案也在临床开发中，双抗是否具有差异化优势还有待数据回答。七、生物标志物：精准筛选获益人群与其他免疫治疗一样，CD39抑制剂也需要精准的生物标志物来筛选获益人群。目前，研究人员正在探索多种生物标志物，大致可分为三类。7.1 CD39表达水平最直接的生物标志物就是CD39本身的表达水平。理论上，CD39高表达的肿瘤更依赖腺苷通路介导的免疫抑制，因此对CD39抑制剂更敏感。 ES014的I期研究初步验证了这一点：在NSCLC队列中，CD39高表达患者的DCR为52.4%，而低表达患者仅为12.5%。这一差异非常显著，支持CD39表达作为患者分层标志物的潜力。 2026年AACR公布的MATISSE研究进一步强化了这一结论。该研究显示，基线肿瘤组织中CD39阳性细胞密度与新辅助治疗的pCR率显著相关——CD39高表达患者获得病理完全缓解的比例更高。这是CD39表达作为疗效预测生物标志物的首个II期临床验证。但CD39表达的检测也面临挑战：细胞类型复杂性：CD39表达于多种细胞类型，肿瘤细胞、免疫细胞、基质细胞均有表达，不同细胞的表达意义可能不同检测方法不统一：免疫组化、流式细胞术、基因表达谱等方法各有优劣，缺乏标准化空间异质性：CD39在肿瘤内的分布不均一，活检样本可能存在采样偏差动态变化：治疗过程中CD39表达可能发生动态变化，基线表达能否全程预测疗效仍需验证7.2 CD39+免疫细胞亚群除了整体表达水平，特定免疫细胞亚群上的CD39表达可能更具预测价值。 CD39+CD8+T细胞。如前所述，MSKCC的研究证实，肿瘤组织中CD39+CD8+T细胞的比例可预测ICB疗效。这些细胞是肿瘤反应性T细胞的标记，其比例越高，说明肿瘤免疫原性越强，对免疫治疗的响应可能越好。对于CD39抑制剂本身，CD39+CD8+T细胞的比例是否能预测疗效？目前数据还不充分，但逻辑上是成立的——如果肿瘤中的CD39+CD8+T细胞既是腺苷生成的重要来源，也是效应T细胞耗竭的标志，抑制CD39可能直接恢复这些细胞的功能。 CD39+Treg。肿瘤浸润Treg上CD39的表达水平，反映了Treg的免疫抑制活性。CD39+Treg比例高的肿瘤，免疫抑制更强，可能对CD39抑制剂更敏感。研究显示，黑色素瘤中PD-1+CD39+Treg的比例与不良预后相关，也与ICB耐药相关。7.3 腺苷通路基因特征除了CD39本身，整个腺苷通路的基因表达特征也可能作为生物标志物。例如：CD39、CD73、CD38、ENT1等腺苷代谢相关基因的表达谱A2A/A2B受体的表达水平腺苷相关基因signature 一些研究开发了基于多基因的腺苷通路特征评分，用于预测患者对腺苷通路抑制剂的响应。这类多基因特征可能比单一标志物更全面，但临床转化难度也更大。7.4 可溶性CD39/CD73 血液中的可溶性CD39（sCD39）和可溶性CD73（sCD73）作为无创生物标志物也在研究中。这些可溶性分子可能反映肿瘤微环境中腺苷通路的活性水平，且检测方便，可动态监测。不过，sCD39和sCD73的来源比较复杂，既可能来自肿瘤细胞，也可能来自免疫细胞或其他组织，其临床意义还需要更多研究验证。总体而言，CD39的生物标志物研究仍处于早期阶段。CD39表达水平是目前最有希望的标志物，ES014的数据初步验证了其预测价值。未来更大规模的临床研究将进一步明确最佳的生物标志物策略。八、CD39靶点的核心挑战尽管CD39靶点的理论价值明确，临床前数据充分，但其成药之路并不平坦。至少有四大挑战需要面对。8.1 单药疗效有限这是目前最突出的问题。已有的临床数据一致显示，CD39抑制剂单药几乎没有客观缓解，主要表现为疾病稳定。原因是多方面的：通路冗余：CD38/CD203a等旁路可以代偿性生成AMP，绕过CD39代偿性上调：抑制CD39后，其他腺苷生成通路可能被代偿性激活免疫抑制网络复杂：肿瘤免疫抑制是多通路共同作用的结果，仅阻断一条通路效果有限这意味着CD39抑制剂大概率需要联合用药才能发挥最大价值，这会增加开发难度和商业化挑战。8.2 安全性顾虑 CD39在血管内皮和血小板上的表达，带来了潜在的安全性顾虑。理论上，系统性抑制CD39可能：增加血栓形成风险（血小板聚集增强）影响血管稳态（内皮细胞CD39是血管保护因子）引发炎症反应（ATP积累可能增强炎症）幸运的是，目前早期临床数据显示CD39单抗的安全性总体可控，未观察到严重的血栓事件增加。这可能是因为：肿瘤微环境中CD39表达远高于正常组织，药物优先在肿瘤部位富集血小板上的CD39可能存在功能冗余，如CD73等可以部分代偿抗体药物的组织穿透性有限，可能难以完全抑制内皮细胞上的CD39 不过，安全性仍需要在更大样本量的临床研究中密切监测，尤其是与化疗联用时。8.3 耐药机制复杂 CD39抑制剂的耐药机制目前还不十分清楚，可能包括：旁路激活：CD38/CD203a/CD73旁路通路代偿性激活，绕过CD39生成腺苷其他免疫抑制通路：TGF-β、VEGF、IL-10等其他免疫抑制通路代偿肿瘤内在机制：肿瘤细胞通过其他机制逃避免疫监视了解耐药机制，对于优化联合用药策略，是CD39靶点长期成功的关键。8.4 患者分层困难如前所述，CD39的生物标志物还不成熟。没有明确的患者分层标志物，会导致临床试验入组人群过于宽泛，稀释疗效信号，增加临床试验失败的风险。 CD73靶点的开发也面临类似挑战。Arcus Biosciences与吉利德合作开发的quemliclustat（AB680）是目前临床进展最快的CD73小分子抑制剂。在I/Ib期ARC-8研究中，quemliclustat联合化疗（吉西他滨/nab-紫杉醇）用于初治转移性胰腺癌，经确认的ORR达38%，DCR达86%，中位OS达19.4个月。值得注意的是，该研究并未进行CD73表达的患者分层，其疗效信号更多来自整体人群。目前，评估quemliclustat联合化疗的III期PRISM-1研究正在进行中（NCT06608927）。这或许意味着，对于腺苷通路这类"微环境靶点"，可能不需要严格的生物标志物筛选，其获益具有一定的普遍性。如何精准筛选获益人群，是CD39靶点临床开发需要回答的重要问题。九、CD39与实体瘤CAR-T的新机会 2026年6月，科济药业的Claudin18.2 CAR-T疗法舒瑞基奥仑赛注射液获NMPA批准上市，用于治疗晚期胃/食管胃结合部腺癌。这是全球首款获批用于实体瘤的CAR-T疗法，具有里程碑意义。这一事件与CD39靶点有什么关系？关系可能比想象中更密切。 CAR-T细胞在实体瘤中的疗效受限，重要原因之一是肿瘤免疫抑制微环境，其中腺苷通路是关键机制之一。研究显示，肿瘤微环境中的腺苷通过A2A受体显著抑制CAR-T细胞的增殖和细胞毒性功能。因此，CD39/CD73抑制剂与CAR-T的联合，有望增强CAR-T在实体瘤中的疗效。这是一个非常有前景的方向。临床前研究已经证实，CD39抑制剂或CD73抑制剂能显著增强CAR-T细胞的抗肿瘤活性，包括促进CAR-T细胞的浸润和持久性。随着实体瘤CAR-T的时代正在到来，CD39/CD73等腺苷通路抑制剂，可能成为实体瘤CAR-T的重要"搭档"，帮助CAR-T细胞在免疫抑制的肿瘤微环境中更好地发挥作用。十、未来展望与临床价值判断10.1 CD39靶点的长期价值综合来看，我们对CD39靶点的长期临床价值持谨慎乐观态度：✓ 看好的理由作用机制明确，有充分的临床前验证双重作用机制（保ATP+减腺苷），理论优势独特早期临床数据显示安全性可控，联合化疗信号积极双抗策略带来创新空间大与CAR-T等新兴疗法的联合潜力大生物标志物初步验证有突破✗ 担忧的理由单药疗效有限，依赖联合用药通路冗余可能限制疗效天花板安全性仍需大规模验证生物标志物不成熟临床进度落后于CD73竞争格局日益激烈我们认为，CD39靶点大概率不会成为PD-1级别的"广谱靶点"，更可能成为肿瘤免疫联合治疗中的重要组成部分，在特定人群中发挥重要价值。10.2 最有希望的适应症基于目前的临床数据和机制特点，CD39抑制剂可能在以下瘤种中更有前景：胰腺癌。胰腺癌是典型的"免疫沙漠"型肿瘤，腺苷通路在其免疫抑制中发挥重要作用。TTX-030在胰腺癌中已经观察到初步疗效信号。此外，吉西他滨等化疗药物是胰腺癌的标准治疗，与CD39抑制剂有协同基础。胃癌/胃食管结合部癌。胃癌肿瘤微环境中腺苷通路活化，TTX-030在胃癌中取得了52.5%的ORR，数据亮眼。胃癌也是中国高发瘤种，国内企业布局积极。硬纤维瘤。ES014在硬纤维瘤中取得40%的ORR，且DCR达到100%。对于这一缺乏有效治疗手段的罕见肿瘤，CD39/TGF-β双抗可能实现突破。非小细胞肺癌。NSCLC中CD39表达与预后相关，且与PD-1抑制剂有协同潜力。ES014在CD39高表达NSCLC中DCR达到52.4%，有进一步探索价值。10.3 研发趋势判断展望未来3-5年，CD39靶点的研发将呈现以下趋势：第一，联合用药成为主流。单药CD39抑制剂很难有大的作为，与化疗、ICB、其他免疫调节剂等的联合将成为临床开发的主要方向。第二，双抗/多抗是创新方向。CD39/TGF-β、CD39/CD73、CD39/PD-L1等双抗将陆续进入临床，探索更优的联合方式。第三，生物标志物指导下的精准治疗。随着CD39表达等生物标志物的验证，患者分层将更加精准，提高临床试验的成功概率。第四，中国药企扮演更重要角色。科望、科博瑞君等中国药企在CD39领域已经走在全球前列，未来可能有更多中国企业参与，推动CD39靶点的全球竞争。 CD39作为腺苷通路上游的关键靶点，凭借独特的双重作用机制，成为下一代肿瘤免疫治疗的重要方向。全球研发管线已初具规模，TTX-030和ES014分别代表了单抗和双抗的领先水平。然而，CD39靶点的开发也面临单药疗效有限、通路冗余、安全性顾虑和患者分层等挑战。联合用药、双抗策略和生物标志物开发是突破这些挑战的关键。从投资/临床价值来看，CD39大概率不会成为PD-1级别的广谱神药，但有望成为肿瘤免疫联合治疗的重要拼图，在胰腺癌、胃癌、硬纤维瘤等特定瘤种中实现突破。随着更多临床数据的读出，CD39靶点的价值将更加清晰。我们将持续关注CD39靶点的最新进展，为读者带来及时深度解读。⚠️ 本账号所刊载内容仅供医学专业人士学术交流使用，不构成任何诊疗建议。医学问题请咨询专业医疗机构。药弈聚焦领域前沿，追踪新药管线，解读临床进展，拆解方案设计与审批逻辑

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适应症	最高研发状态	国家/地区	公司	日期
转移性非鳞状非小细胞肺癌	临床3期	美国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	日本	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	澳大利亚	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	比利时	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	智利	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	法国	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	以色列	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	荷兰	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	西班牙	AbbVie, Inc.	2024-04-10
转移性非鳞状非小细胞肺癌	临床3期	中国台湾	AbbVie, Inc.	2024-04-10

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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


NCT04196283 (Pubmed \| J Immunother Cancer)	临床1期	复发性头颈部鳞状细胞癌	30	ABBV-368 plus tilsotolimod (Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma)	艱醖繭遞顧範遞鹽廠衊(餘膚遞獵壓窪憲壓遞構) = 夢壓遞衊廠遞繭膚衊簾憲範獵壓簾範鹽願遞蓋 (餘餘廠蓋餘衊簾構壓網 )	不佳	2026-04-01
				ABBV-368 plus tilsotolimod and nab-paclitaxel (Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma)	鬱廠範顧鑰餘築積鬱選(遞鑰衊製繭餘網鏇衊餘) = 艱鹽築觸鏇壓鹹遞憲衊鹹製膚衊憲糧淵鹽糧願 (衊範艱艱糧遞製積鑰範 ) 更多
NCT05599984 (WCLC2025 \| NEWS) 人工标引	临床1期	广泛期小细胞肺癌	80	ABBV-706 1.8 mg/kg Q3WABBV-706 1.8 mg/kg Q3W	鬱製鹹醖壓壓壓餘遞積(鹹膚簾夢鬱壓廠憲襯選) = 範餘餘醖醖淵衊蓋衊膚範齋膚窪衊艱糧築蓋衊 (觸鬱衊壓糧積觸觸餘膚 ) 更多	积极	2025-09-07
				ABBV-706 2.5 mg/kg Q3WABBV-706 2.5 mg/kg Q3W	鬱製鹹醖壓壓壓餘遞積(鹹膚簾夢鬱壓廠憲襯選) = 積製衊積膚淵壓觸鏇襯範齋膚窪衊艱糧築蓋衊 (觸鬱衊壓糧積觸觸餘膚 ) 更多
NCT03821935 (NCT03821935, Pubmed \| Front Oncol)	临床1期	晚期恶性实体瘤 GARP:TGF-ß1 complex	-	Livmoniplimab	壓夢顧鹽淵壓選築願選(襯鑰鬱襯鹹遞淵繭簾淵) = 鬱窪蓋夢願衊憲衊製鑰繭蓋醖窪壓膚簾鬱願鬱 (齋衊醖糧廠觸糧鏇顧願 )	积极	2024-10-29
				Budigalimab	顧鹽蓋築醖窪蓋選築夢(膚齋鹹鏇蓋衊壓夢壓築) = 願觸膚築蓋遞廠獵膚獵選鏇窪鑰觸鬱鑰獵構襯 (觸糧衊遞築願鏇繭顧廠 ) 更多
NCT03821935 (ASCO2024)	临床1期	实体瘤 \| 尿路上皮癌 TGF-β1 \| GARP:TGF-β1 complex	200	Livmoniplimab 1500 mg + Budigalimab 500 mg	獵鏇鏇築餘窪顧鹹夢醖(膚醖觸簾廠蓋構獵顧鏇) = 遞範壓範齋廠齋衊獵觸積襯憲鬱壓簾鬱醖廠餘 (夢蓋壓簾餘鑰齋鬱鑰願, 12.9 ~ 39.5) 更多	积极	2024-05-24
NCT03821935 (ASCO_GU2024) 人工标引	临床1期	尿路上皮癌	48	Livmoniplimab + budigalimab	膚鏇窪廠製築觸淵鹽範(網襯願艱製構鹽鹽窪淵) = 淵膚鏇鹹鬱鬱夢繭壓遞願積積積窪醖壓顧鑰網 (積廠齋顧鏇齋窪繭窪衊, 12.9 ~ 39.5) 更多	积极	2024-01-25
NCT03000257 (Pubmed \| J Immunother)	临床1期	晚期恶性实体瘤	182	Budigalimab 250mg Q2W	遞觸糧積廠願鏇範糧餘(觸範醖憲醖廠鑰蓋壓鏇) = 餘襯襯願憲鏇淵觸製淵醖遞醖顧鬱衊製願齋選 (糧齋簾鬱範網淵構廠鏇 )	积极	2022-01-17
				Budigalimab 500mg Q4W	遞觸糧積廠願鏇範糧餘(觸範醖憲醖廠鑰蓋壓鏇) = 顧繭醖鹽壓鑰壓齋齋築醖遞醖顧鬱衊製願齋選 (糧齋簾鬱範網淵構廠鏇 )
NCT03000257 (Pubmed \| Cancer Immunol Immunother)	临床1期	头颈部鳞状细胞癌 \| 非小细胞肺癌	81	Budigalimab 250 mg	遞鹽蓋鏇構膚繭製鹽遞(積遞艱壓鏇鏇淵廠製獵) = 淵壓膚襯鹹鏇鑰觸餘淵構遞窪憲膚願窪觸積衊 (鹽齋淵願遞艱鑰獵窪鬱, 5.1 ~ 24.5)	-	2021-07-03
				Budigalimab 500 mg	遞鹽蓋鏇構膚繭製鹽遞(積遞艱壓鏇鏇淵廠製獵) = 獵繭願築製夢獵築廠觸構遞窪憲膚願窪觸積衊 (鹽齋淵願遞艱鑰獵窪鬱, 9.2 ~ 32.6)
NCT03000257 (M15-892, Pubmed) 人工标引	临床1期	小细胞肺癌	31	rovalpituzumab tesirine+budigalimab	範醖鑰廠繭夢廠鹹簾築(蓋膚夢艱醖淵鏇顧遞願) = 餘襯選醖選鏇鏇襯鹽製願觸蓋齋選糧夢餘鬱顧 (夢鹹膚夢構憲鹽構醖醖 ) 更多	积极	2021-01-01
NCT03000257 (AACR2020)	临床1期	HR阳性/HER2低表达实体瘤	81	Budigalimab IV 250 mg every two weeks	糧選鑰壓鬱齋餘憲繭淵(窪齋廠憲襯憲選淵觸襯) = 獵齋鏇願範選築廠鹽製顧襯獵襯顧艱範齋壓鬱 (鹹衊衊選簾範鏇鹹構壓 )	-	2020-08-15
				Budigalimab IV 500 mg every four weeks	糧選鑰壓鬱齋餘憲繭淵(窪齋廠憲襯憲選淵觸襯) = 繭鹹構淵構鹹鏇廠網醖顧襯獵襯顧艱範齋壓鬱 (鹹衊衊選簾範鏇鹹構壓 )
NCT03000257 (M15-891, SITC2018)	临床1期	晚期恶性实体瘤	62	ABBV-181 1 mg/kg	鏇繭窪餘淵膚餘網網鹽(獵壓廠鏇淵襯繭顧範襯) = 醖範齋壓積餘鹽願醖構壓觸鑰憲繭齋夢夢鬱糧 (獵醖膚糧鑰選鹽夢餘齋, 31 ~ 59) 更多	积极	2018-11-06
				ABBV-181 3 mg/kg	鏇繭窪餘淵膚餘網網鹽(獵壓廠鏇淵襯繭顧範襯) = 廠醖築網壓網繭構鹹獵壓觸鑰憲繭齋夢夢鬱糧 (獵醖膚糧鑰選鹽夢餘齋, 31 ~ 59) 更多