IMMUNORARE5: A National Platform of 5 Academic Phase II Trials Coordinated by Lyon University Hospital to Assess the Safety and the Efficacy of the IMMUNOtherapy With Domvanalimab + Zimberelimab Combination in Patients With Advanced RARE Cancers

Immune checkpoint inhibitors (ICI) have revolutionized the management of advanced cancers. However, most rare cancers have been excluded from this progress due to the lack of clinical trials involving these diseases. After the standard first-line treatment, there are no other validated treatments for most of them. The management of these patients in ≥ 2nd line treatment relies on historic poorly effective regimens.
This creates an inequity between patients with frequent cancers beneficiating from medical progresses and approvals of innovative drugs, and patients with rare cancers are still treated with old and toxic drugs.
Few available data on case reports and early phase studies indicate a beneficial role of the immunotherapy in rare cancers.
The investigators assume that the combination of Domvanalimab and Zimberelimab is more effective than historical standard treatments in patients with 5 types of advanced rare cancers, after failure of at least one line of standard treatment in the advanced setting:
* Cohort 1: Peritoneal Mesotheliomas (PM)
* Cohort 2: Gestational Trophoblastic Tumors (GTT)
* Cohort 3: B3 Thymomas and Thymic Carcinomas (TET)
* Cohort 4: Refractory Thyroid Carcinomas (ATC)
* Cohort 5: GEP-NET and carcinoid tumors (GEP-NET (Gastroenteropancreatic neuroendocrine tumors)/TCT (Thoracic carcinoid tumor)/UP-NET (Neuroendocrine tumor of unknown primary))
The primary objective is to assess the efficacy of the combination of Domvanalimab and Zimberelimab in terms of progression-free survival rate at 24 weeks (for cohorts 1,3,5), successful hCG (Human Chorionic Gonadotropin) normalisation rate at 24 weeks for cohort 2 and survival rate for cohort 4.
The secondary objectives are to assess the efficacy of the combination of anti-TIGIT (T cell Immunoreceptor with Ig and ITIM domains) and anti-PD-1 (Programmed Death-1) immunotherapies in terms of overall response rate, progression-free survival (cohort 1-3 and 5), resistance-free survival (cohort 2), overall survival (cohorts 1-3 and 5), duration of the response (cohorts 1-3 and 5); and to assess the tolerability of the doublet of immunotherapy in terms of adverse events.
Patients will be treated until disease progression or alternatively 2 years in case of complete response (upon discussion with the coordinator of the study, the coordinator of the cohort and the investigator), unacceptable toxicity, or death. At the end of treatment, patients will be followed up for at least 1 year.
IMMUNORARE5 is composed of five independent open-label national multicenter single-arm phase II trials, sponsored by Lyon University Hospital, led in collaboration with the corresponding French national reference centers, with a centralized coordination by a dedicated team.
Each phase II trial is designed as a two-stage Simon design, with early termination for futility. For each cohort, a null hypothesis (H0) and an alternative hypotheses (H1) regarding the percentages of patients with success has been defined, with 5% one-sided alpha level and 80% power.
The trial will be conducted in 15 French Centers with an inclusion period of 36 months

开始日期2025-05-01

申办/合作机构

Hospices Civils de Lyon

NCT06431633

/ Not yet recruiting临床3期IIT

A Phase III Clinical Trial of Adjuvant Treatment with Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant Treatment_ARIAN

Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.
129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment.
This clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles.
The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.
Patient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.

开始日期2025-03-01

申办/合作机构-

NCT06250036

/ Not yet recruiting临床2期IIT

A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +/- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma

A phase II study of peri-operative anti-PD1 (Zimberelimab) +/- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)/ high micro-satellite instability (MSI-H) gastric/gastro-oesophageal junctional (GOJ) adenocarcinoma (AC)

开始日期2025-01-31

申办/合作机构

Royal Marsden NHS Foundation Trust

[+1]

100 项与赛帕利单抗相关的临床结果

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100 项与赛帕利单抗相关的转化医学

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100 项与赛帕利单抗相关的专利（医药）

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项与赛帕利单抗相关的文献（医药）

2025-02-01·LEUKEMIA RESEARCH

Long-term follow-up of zimberelimab in relapsed or refractory classic Hodgkin lymphoma: Insights from the phase Ⅱ YH-S001-04 clinical trial

Article

作者: Lin, Ningjing ; Liu, Zhuogang ; Xu, Bing ; Zhao, Xielan ; Wang, Li ; Zang, Aimin ; Jiang, Yongsheng ; Zhang, Ying ; Zhang, Zhihui ; Ke, Xiaoyan ; Zhou, Hui ; Zhang, Huilai ; Hu, Chunhong ; Liu, Hui ; Yan, Dongmei ; Cui, Jie ; Qi, Junyuan ; Zhang, Mingzhi ; Shao, Zonghong ; Shi, Jinsheng ; Kan, Suisui ; Yang, Shenmiao ; Liu, Lihong ; Xiang, Ying ; Bai, Hai

BACKGROUND:

Treating relapsed or refractory classical Hodgkin lymphoma (R/R cHL) remains challenging. This report extends the three-year follow-up period for the phase Ⅱ YH-S001-04 trial, expanding upon the initial 15.8-month analysis.

METHODS:

Zimberelimab 240 mg was administered every two weeks for two years or until disease progression or death. The endpoint was the objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

The median follow-up was 38.0 months (3.5-42.8 months). The ORR was 91.6 % (95 % CI, 83.8-95.9). Median PFS was 23.6 months, with a longer PFS in responders (28.5 months) compared to non-responders (9.2 months) (P=0.0098). Complete responders had longer mPFS than partial responders (Not reached vs. 28.5 months, P=0.3469). Relapsed patients had improved mPFS compared to refractory cHL (23.6 vs. 10.6 months, P=0.0061). Patients with ＜3 lines of therapy showed longer mPFS compared to ≥3 lines (not reached vs. 23.6 months, P=0.0095). The 3-year OS rate was 94.0 % (95 % CI, 85.9-97.4). No serious adverse events with incidence >5 %.

CONCLUSIONS:

With encouraging data on both PFS and OS, zimberelimab demonstrates ongoing efficacy and safety in treating R/R cHL, supporting zimberelimab as an effective treatment alternative for R/R cHL (NCT03655483).

2025-01-01·SAGE Open Medical Case Reports

Advanced anaplastic thyroid carcinoma with positive expression of PD-L1 response to immune checkpoint inhibitors: A case report

Article

作者: Sang, Die ; Yuan, Yang ; Fan, Shanmin ; Su, Yanfang

Anaplastic thyroid carcinoma (ATC) is one rare type of thyroid carcinoma without standard systemic treatment for advanced disease. Recent evidence has demonstrated promising efficacy of immune checkpoint inhibitors, particularly those targeting programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1), in a variety of solid tumors. However, there have been no research of immune checkpoint inhibitors plus chemotherapy in ATC. Here, we present the case of a 37-year-old man with metastatic ATC with positive PD-L1 expression, who achieved long-term remission of 34 months after later-line treatment with zimberelimab (a PD-1 inhibitor) and nab-paclitaxel, followed by single-agent zimberelimab maintenance therapy. After three cycles of the combination treatment, the thyroid lesion and the liver metastases shrank dramatically, leading to the best overall response of partial remission. PD-L1 expression may serve as a potential biomarker for tumor response to immune checkpoint inhibitors in ATC. Our review highlights the need for further studies investigating the role of PD-L1 status as biomarker to predict the prognosis of immunotherapy in the treatment of ATC.

2024-09-01·JOURNAL OF PHARMACEUTICAL SCIENCES

Translate Pharmacokinetics of PD-1/PD-L1 Monoclonal Antibodies from Cynomolgus Monkey to Human: Comparison of Different Approaches

Article

作者: Wang, Lu ; Jiang, Bo ; Chen, Wenjun ; Lou, Honggang ; Ruan, Zourong

Antibodies blocking programmed death-1 (PD-1) and its natural ligand programmed death-ligand 1 (PD-L1) have been proved to be promising strategies in recent years. Hundreds of PD-1/PD-L1 antibodies are under development worldwide. Prediction of human pharmacokinetics (PK) in the preclinical stage is critical for designing dosing regimens in first-in-human studies. This study aims to predict the PK of PD-1/PD-L1 antibodies in human by scaling of monkey data. A systematic literature search of published articles on the PK of PD-1/PD-L1 antibodies in cynomolgus monkey and in human was conducted. Allometric scaling (AS), the species time-invariant (STIV) method, as well as physiologically based pharmacokinetic (PBPK) modeling were investigated. Six antibodies (avelumab, atezolizumab, nivolumab, pembrolizumab, cemiplimab, and zimberelimab) were included for investigation. The exponents used in this study were 0.85 and 1 for clearance (CL) and distribution volume (V), respectively, both for AS and STIV methods. The generic PBPK model for macromolecules in PK-Sim was used without further modifications. The dissociation constant of the antibody for binding to FcRn (K_D) in endosome space for human was assumed to be two-fold of that for monkey. Predicted human CLs for the majority of drugs were within the observed range, while Vs were not well predicted using the AS method. The STIV method and the generic PBPK model can be employed to translate concentration-time curves of PD-1/PD-L1 antibodies from cynomolgus monkey to human with comparable efficacy. The results of this study provide reference for the early development of PD-1/PD-L1 antibodies.

250

项与赛帕利单抗相关的新闻（医药）

2025-02-12

·Endpoints

New CMO Dietmar Berger highlights Gilead’s ‘unique situation’ and its HIV ambitions

Dietmar Berger said Gilead is in a “unique situation” as he assumes the role of chief medical officer, touting a “well-diversified” pipeline, potential launches and an eight-year stretch of no major patent cliffs. Berger will be tasked with leading Gilead’s R&D comeback, following a tough year for its cancer pipeline that brought disappointing readouts and a withdrawal for Trodelvy in urothelial cancer. Six weeks in, Berger told investors and analysts Tuesday that he is “impressed with the outstanding talent we have across therapeutic areas here at Gilead, and the depth of innovation across our 54 clinical programs.” Gilead’s HIV franchise will be a big part of Berger’s plans, including an anticipated US launch this year for Sunlenca in HIV pre-exposure prophylaxis (PrEP), and ongoing programs assessing daily, weekly and monthly oral treatment options and quarterly and twice-annual injectable options. Sunlenca, also known as lenacapavir, is already approved for use in combination with other antiretroviral drugs to treat people with multidrug-resistant HIV infection. Two of Gilead’s programs aren’t making the R&D pivot: a Phase 1 long-acting injectable for HIV treatment called GS-6212, and an Arcus-partnered combination regimen in Phase 2 for metastatic non-small cell lung cancer. Discontinuation of GS-6212 was announced in December, as the company chose to advance another program called GS-1614 in combination with Sunlenca instead. A Gilead spokesperson called the removal of its Arcus-partnered combination a “strategic prioritization decision.” The program was evaluating domvanalimab, zimberelimab and etrumadenant, and Gilead continues to study those molecules in other combination studies. Executives also touted a strong launch for Livdelzi, Gilead’s primary biliary cholangitis drug that was approved in August. The company said fourth-quarter liver disease sales totaled $719 million, up 4% from the year prior, driven in part by the Livdelzi launch. “Not only are we seeing the progression, but it’s definitely exceeding our internal expectations,” chief commercial officer Johanna Mercier said on the company’s earnings call. However, Mizuho analysts said Tuesday that Sunlenca’s potential launch in HIV PrEP this summer is “arguably the most anticipated” milestone for Gilead this year. “Our many near-term opportunities across HIV, oncology and inflammation will help to drive the next wave of growth for Gilead,” CEO Daniel O’Day said. “We have no major loss of exclusivity until late 2033 and we have significant potential across the entire portfolio.”

临床2期上市批准临床1期高管变更

2025-01-08

·ir.cgen.com

Compugen Announces First Patient Dosed in Phase 1 Clinical Trial to Evaluate COM503 as Monotherapy and in Combination with Zimberelimab in Advanced Solid Tumors

New approach to harness cytokine biology to treat cancer patients advances to the clinic First patient dosed with potential first-in-class anti-IL-18 binding protein antibody, COM503, licensed to Gilead Sciences, Inc. Phase 1 dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as monotherapy and in combination for patients with advanced solid tumors Compugen responsible for running the Phase 1 trial HOLON, Israel, Jan. 8, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that the first patient was dosed in a Phase 1 clinical trial with COM503, a potential first-in-class antibody against IL-18 binding protein licensed by Compugen to Gilead. Compugen is responsible for running the Phase 1 trial. This Phase 1 multi-center dose escalation and dose expansion trial will evaluate the safety, tolerability, and pharmacokinetics of COM503 as monotherapy and in combination with Gilead's anti-PD1, zimberelimab in patients with advanced solid tumors. The trial was initiated in the fourth quarter of 2024 as planned. "We are delighted to advance COM503, our antibody that provides a new and potentially differentiated approach to harness cytokine biology for cancer therapeutics, quickly into the clinic," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "Compugen's discovery engine Unigen™, identified that the tumors of patients with cancer express high levels of IL-18. However, the anti-tumor activity of IL-18 is blocked by an endogenous IL-18-binding protein, rendering it ineffective in fighting cancer. By blocking this endogenous IL-18 binding protein, COM503 presents a unique opportunity to release naturally occurring IL-18 locally within the tumors, where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines." Manish Sharma, M.D., Co-Director of Clinical Research, at the START Center for Cancer Research-Midwest (START Midwest) in Grand Rapids, Michigan, added, "Having COM503 as an additional novel investigational treatment option with a unique mechanism of action to offer our cancer patients is exciting. We, at START Midwest, were delighted to be the first to dose a patient with COM503 and look forward to swiftly enrolling additional patients in this first dose escalation part of the trial with a focus on evaluating the safety and pharmacokinetics of COM503 monotherapy." About the COM503 Phase 1 trial: The primary objectives of this trial are to assess the safety and tolerability of COM503 as a monotherapy and in combination with zimberelimab in patients with advanced solid tumors and to identify the maximum tolerated dose /maximum administered dose and/or the recommended dose of COM503 as monotherapy and in combination with zimberelimab. For more information about the Phase 1 clinical trial, visit clinicaltrials.gov, NCT06759649. About the Compugen-Gilead license agreement In December 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including the COM503 drug candidate. Compugen managed the preclinical development of COM503 and is responsible for the Phase 1 trial evaluating the safety and tolerability of COM503. Thereafter, Gilead will have sole right to develop and commercialize COM503. Gilead paid Compugen $60 million as upfront payment and $30 million as COM503 IND clearance milestone. Compugen is eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of up to $848 million. Compugen is also eligible to receive single-digit to low double-digit tiered royalties on worldwide net sales. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (Unigen™) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Compugen Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statement regarding our belief that by blocking IL-18 binding protein, COM503 presents a unique opportunity to release naturally occurring IL-18 locally within the tumors, where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Gaza; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Yvonne Naughton, Ph.D. VP, Head of Investor Relations, and Corporate Communications Email: ir@cgen.com Tel: +1 (628) 241-0071 View original content:https://www.prnewswire.com/news-releases/compugen-announces-first-patient-dosed-in-phase-1-clinical-trial-to-evaluate-com503-as-monotherapy-and-in-combination-with-zimberelimab-in-advanced-solid-tumors-302345677.html SOURCE Compugen Ltd.

临床1期引进/卖出免疫疗法临床3期

2024-12-27

·医药投资部落

割肉PD-1，却遭遇“老赖”

截至2023年底，中国市场共有17款PD-(L)1药物获批上市，其中包括11款PD-1和6款PD-L1。在单一品种上如此高烈度的集中竞争，个中甘苦，只有入场的玩家才能体会。 2023年，A股上市药企誉衡药业，决定不玩了，彻底割肉出局。 2023年6月28日，誉衡药业发布公告称，公司拟将持有的子公司誉衡生物42.12%股权对外转让，对应的交易金额为2.4亿元，交易对手方是青岛普晟普利企业管理中心（有限合伙）。这是一场彻底清仓式的出局：本次交易完成后，公司将不再持有誉衡生物的股权。誉衡生物，正是承载誉衡药业PD-1业务的子公司。 2021年8月，誉衡生物的抗PD-1单抗赛帕利单抗注射液成功获批上市，用于二线治疗霍奇金淋巴瘤。从上市时间来看，赛帕利单抗已经落后于国内相当多的同行，从适应症来看，二线霍奇金淋巴瘤的市场空间也难言乐观。在2022年，也就是上市之后的首个完整销售年度，赛帕利单抗卖出去5.34万支，对应当年誉衡生物的销售收入为1.21亿，亏损5.89亿。这种拉胯的表现，直接导致作为上市公司的誉衡药业交出了一份糟糕的年报：2022年度，誉衡药业的净利润为-2.7亿。如果2023年度誉衡生物继续产生大额的亏损，很有可能连累上市公司誉衡药业的净利润再次为负。在退市制度日益严格的今天，如果连续若干年净利润为负，对于上市公司来说，无异于在悬崖边蹦迪。站在誉衡药业的角度，果断地丢车保帅，与亏损资产尽快切割，是一个无奈但是又非常现实的选择。但是，如果说当年选择入局PD-1药物市场是誉衡药业的一次“踩坑”，那么这次转让子公司誉衡生物的股权，则是誉衡药业的又一次“踩坑”。因为在整整一年半以后，誉衡药业还没有收到足额的转让款。 2024年4月，誉衡药业正式起诉青岛普晟普利。根据当时的公告信息透露，作为誉衡生物股权的买方，青岛普晟普利在支付了51%的款项（约1.224亿）之后，剩下的49%的款项（约1.176亿）就一直没有支付。这是遇上老赖了。 2024年12月，法院于2024年12月27日作出一审判决，要求被告在判决生效后十日内支付该股权转让款及违约金，违约金按1.18亿元为基数，自2024年1月1日起计算至实际给付之日止。但是，法院判决，不等于可以立即执行。仅从公开信息来看，拥有PD-1业务的誉衡生物，状况并不好。工商信息显示，誉衡生物已经涉及6起被执行人案件，执行总金额达到395.47万元。誉衡药业何时可以全款收回转让誉衡生物的对价，目前还存在不确定性。但是如果抛开这笔股权转让的“烂账”不谈，在割肉PD-1并退守原先的仿制药、中成药领域之后，誉衡药业的状态可以说非常不错。 2024年7月上旬，A股上市药企誉衡药业发布2024年半年度业绩预告，预计今年上半年录得归母净利润1亿元~1.3亿元，同比预增253.99%~360.19%；录得扣非净利润0.8亿元~1亿元，同比预增198.80%~273.50%。这将是自从2020年以来，誉衡药业扣非净利润数字最高的一份半年业绩。在总结盈利原因是，誉衡药业提到：公司于2023年出售了持有的广州誉衡生物科技有限公司（以下简称“誉衡生物”）全部股权，誉衡生物的亏损不再影响公司 2024 年半年度损益。医药研究报告分享营收集与分享全市场主流医药研究报告每天仅需0.8元畅享超过2000篇存量精选医药研究报告每年新增额外500篇

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外链

KEGG	Wiki	ATC	Drug Bank
D12063	-	-	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
PD-L1阳性宫颈癌	中国	广州誉衡生物科技有限公司	2023-06-30
霍奇金淋巴瘤	中国	广州誉衡生物科技有限公司	2021-08-25

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
子宫颈转移癌	临床3期	中国	广州誉衡生物科技有限公司	2023-05-01
食管腺癌	临床3期	美国	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	日本	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	阿根廷	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	澳大利亚	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	比利时	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	巴西	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	加拿大	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	智利	吉利德（上海）医药科技有限公司	2022-11-21
食管腺癌	临床3期	法国	吉利德（上海）医药科技有限公司	2022-11-21

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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


NCT04999761 (Zimberelimab platform study, ASCO_GI2025)	临床1期	转移性食管癌一线	43	Zimberelimab 360 mg	築選蓋遞鏇範鏇餘壓觸(獵餘艱膚鬱夢襯遞範鏇) = 淵鏇積廠壓廠鏇衊襯廠窪築齋衊繭糧衊積簾鏇 (蓋齋積選鹽蓋觸觸選餘, 42.1 ~ 73.7) 更多	积极	2025-01-23
NCT04999761 (Zimberelimab platform study, ASCO_GI2025)	临床1期	转移性食管癌一线	43	Futibatinib 20 mg	襯鹹築淵顧餘窪積鏇糧(獵襯鏇鏇鹽憲鬱衊遞簾) = 繭蓋窪鹽鏇鏇選積襯構鑰糧築獵窪構廠艱獵鏇 (壓積蓋獵醖糧構築積壓 )	积极	2025-01-23
NCT04736173 (ARC-10, BusinessWire) 人工标引	临床1期	PD-L1阳性非小细胞肺癌 PD-L1 High Expression	98	Domvanalimab plus Zimberelimab	觸鹽壓網網選顧鹹簾廠(醖鬱襯簾願壓醖網齋齋) = 網醖憲願鹽遞鑰簾廠艱網憲壓鏇選襯醖膚壓蓋 (壓齋糧鑰膚繭簾選餘願, 13.7 ~ NE) 更多	积极	2024-11-05
NCT04736173 (ARC-10, BusinessWire) 人工标引	临床1期	PD-L1阳性非小细胞肺癌 PD-L1 High Expression	98	Zimberelimab	觸鹽壓網網選顧鹹簾廠(醖鬱襯簾願壓醖網齋齋) = 餘廠製窪窪鬱膚壓鹹衊網憲壓鏇選襯醖膚壓蓋 (壓齋糧鑰膚繭簾選餘願, 7.8 ~ NE) 更多	积极	2024-11-05
NCT03972722 (phase II study, Pubmed \| Int J Gynecol Cancer)	临床2期	子宫颈转移癌 programmed death ligand-1-positive	105	Zimberelimab 240 mg	齋構糧糧積範顧構鏇壓(範選鏇鹹醖鹽夢憲積淵) = 19.0% 積範選餘網鏇淵廠製醖 (醖鬱衊鬱夢壓積壓鑰襯 ) 更多	积极	2023-12-01
NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	zimberelimab	襯築鹽鬱鑰製膚觸窪壓(積衊鬱願醖積餘積餘夢) = 簾築鏇築鹽廠夢襯顧廠艱製膚膚鑰齋糧鏇遞鏇 (鹽襯獵艱簾餘鬱積顧網, 17.9 ~ 44.6) 更多	积极	2023-06-03
NCT04262856 (ARC-7, Corporate Publications) 人工标引	临床2期	非小细胞肺癌一线	150	domvanalimab + zimberelimab	襯築鹽鬱鑰製膚觸窪壓(積衊鬱願醖積餘積餘夢) = 簾鏇餘壓範餘艱蓋繭膚艱製膚膚鑰齋糧鏇遞鏇 (鹽襯獵艱簾餘鬱積顧網, 26.4 ~ 54.8) 更多	积极	2023-06-03
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	zimberelimab	餘糧簾夢鹽膚蓋衊鑰鹹(膚網壓觸顧獵觸積糧淵) = 網衊壓淵範壓窪鏇繭鏇蓋壓遞選膚網獵鏇齋顧 (觸獵餘鑰襯顧衊蓋範繭, 15.0 ~ 42.8) 更多	积极	2022-12-20
NCT04262856 (ARC-7, ASCO2022) 人工标引	临床2期	转移性非小细胞肺癌一线 PD-L1 High Expression	149	domvanalimab+zimberelimab	餘糧簾夢鹽膚蓋衊鑰鹹(膚網壓觸顧獵觸積糧淵) = 糧願艱鹹構簾遞艱觸鑰蓋壓遞選膚網獵鏇齋顧 (觸獵餘鑰襯顧衊蓋範繭, 26.3 ~ 56.8) 更多	积极	2022-12-20
NCT03972722 (SITC2022 \| ESMO_IO2022) 人工标引	临床2期	宫颈癌	90	zimberelimab	製糧醖廠積製膚築構鹽(糧鬱觸膚鹹壓築憲齋鹽) = 獵衊鑰壓積築醖齋獵網獵衊艱淵鹹廠獵糧網鬱 (顧窪製願窪餘鹹衊選艱, 18.85 ~ 38.22) 更多	积极	2022-12-08
NCT03972722 (CSCO2022)	临床2期	复发性宫颈癌 \| 转移性宫颈癌	105	赛帕利单抗(GLS-010)注射液	襯網醖顧膚糧鹹壓範範(膚鏇簾鹽鹽鬱齋選夢壓) = 積憲繭醖獵願範鹹憲範夢獵壓蓋齋糧繭鏇選範 (簾壓鑰夢窪顧襯淵餘遞 ) 更多	-	2022-09-21
NCT03655483 (Pubmed \| Eur J Cancer Care (Engl) \| Eur J Cancer) 人工标引	临床2期	典型霍奇金淋巴瘤三线	85	zimberelimab	製鬱鬱觸築網餘夢鏇範(鏇壓窪鏇襯獵憲選鏇壓) = 蓋繭鏇願選蓋築築憲醖鹽糧醖襯齋糧製鏇網鏇 (製顧鏇齋齋窪廠繭夢衊, 82.3 ~ 95.9) 更多	积极	2021-08-27
NCT03713905 (Pubmed \| Eur J Cancer Care (Engl) \| Eur J Cancer) 人工标引	临床1期	HR阳性/HER2低表达实体瘤 \| 淋巴瘤	289	GLS-010	簾積築醖構憲鹹簾膚蓋(憲鏇積願醖鑰鬱鹽鹹衊) = anemia, leukopenia, elevated alanine aminotransaminase/asparate aminotransferase (ALT/AST), and elevated bilirubin 鹹築淵選窪夢鏇憲築夢 (選醖網憲壓鏇獵壓餘鏇 ) 更多	积极	2021-05-01
NCT03713905 (CSCO2020)	临床1期	晚期尿路上皮癌 \| 转移性尿路上皮癌	36	GLS-010(赛帕利单抗)	糧淵糧顧糧餘遞窪製鹹(繭選衊夢蓋醖簾糧選壓) = 餘簾夢觸鹽襯壓鹹憲齋範範願鹹鬱獵簾夢繭選 (鏇廠繭齋遞窪壓鑰獵遞, 20.8 ~ 53.8) 更多	-	2020-09-19