Drugs / Zimberelimab
last change Aug 2026 re-read 2 minutes ago

Zimberelimab

also known as GLS-010 · AB122 · ZIM

Monoclonal antibody targets PDCD1 via inhibition

Developed for
non-small cell lung carcinoma · cervical cancer · cancer · castration-resistant prostate carcinoma · classic Hodgkin lymphoma · colorectal cancer · gastroesophageal junction adenocarcinoma · melanoma
+52 more · pancreatic ductal adenocarcinoma · triple-negative breast carcinoma · biliary tract cancer · cholangiocarcinoma · esophageal cancer · gastric adenocarcinoma · gastric cancer · head and neck squamous cell carcinoma · infiltrating bladder urothelial carcinoma · non-small cell squamous lung carcinoma · renal cell carcinoma · urothelial carcinoma · adenocarcinoma · alveolar soft part sarcoma · breast cancer · carcinoid tumor · cervical carcinoma · clear cell renal carcinoma · cutaneous neuroendocrine carcinoma · dedifferentiated liposarcoma · diffuse large B-cell lymphoma · digestive system cancer · digestive system neuroendocrine neoplasm · endometrial cancer · gastroesophageal cancer · gestational trophoblastic neoplasm · glioblastoma · head and neck cancer · hepatocellular carcinoma · hypopharynx squamous cell carcinoma · larynx cancer · malignant exocrine pancreas neoplasm · metastasis from malignant tumor of colon · metastatic malignant neoplasm · metastatic prostate carcinoma · neoplasm · neuroendocrine carcinoma · oral cavity squamous cell carcinoma · oropharynx squamous cell carcinoma · ovarian cancer · ovarian clear cell cancer · pancreatic adenocarcinoma · pancreatic adenosquamous carcinoma · pancreatic neoplasm · peritoneal mesothelioma · plasma cell myeloma · rectal cancer · thymic carcinoma · thyroid gland undifferentiated (anaplastic) carcinoma · urinary bladder cancer · vaginal neoplasm · vulva cancer
Investigated by
Arcus Biosciences, Inc. · Gilead Sciences · Guangzhou Gloria Biosciences Co., Ltd. · Sun Yat-sen University · Taiho Pharmaceutical Co., Ltd. · Hospices Civils de Lyon
+44 more · Shanghai Zhongshan Hospital · Apices Soluciones S.L. · Cancer Prevention Research Institute of Texas · Catherine Spina · Coherus Oncology, Inc. · Compugen Ltd · Dana-Farber Cancer Institute · Diwakar Davar · Federation Francophone de Cancerologie Digestive · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Fudan University · Fundación GECP · Fundación para el Progreso de la Oncología en Cantabria · Gateway for Cancer Research · Gulam Manji · H. Lee Moffitt Cancer Center and Research Institute · James Cleary, MD, PhD · Jennifer Choe · Jiangsu Cancer Institute & Hospital · Jonsson Comprehensive Cancer Center · Lustgarten Foundation · M.D. Anderson Cancer Center · Massachusetts General Hospital · MedSIR · Memorial Sloan Kettering Cancer Center · Merck KGaA, Darmstadt, Germany · Nataliya Uboha · National Cancer Institute (NCI) · Obstetrics & Gynecology Hospital of Fudan University · Peking University Third Hospital · RemeGen Co., Ltd. · Royal Marsden NHS Foundation Trust · Strata Oncology · Surface Oncology · Suzhou Municipal Hospital · Taiho Oncology, Inc. · Tang-Du Hospital · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University of Texas Southwestern Medical Center · University of Wisconsin, Madison · Washington University School of Medicine · Weill Medical College of Cornell University · Xuekui Liu · Yale University

Trials 68 · started per year

today
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7
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20
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2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT04656535 Apr 2021 → Mar 2026 overdue glioblastoma Yale University Active not recruiting No outcome recorded
Phase 115 trials
Phase 1 NCT06759649 Jan 2025 → Nov 2027 expected cancer Compugen Ltd Recruiting No outcome recorded
Phase 1 NCT06532565 Jul 2024 → Jun 2028 expected cancer Gilead Sciences Recruiting No outcome recorded
Phase 1 NCT04892875 Dec 2023 → Dec 2025 hypopharynx squamous cell carcinoma, larynx cancer, oral cavity squamous cell carcinoma, oropharynx squamous cell carcinoma Jennifer Choe Withdrawn No outcome recorded
Phase 1 NCT06082960 Oct 2023 → Dec 2026 expected cancer Gilead Sciences Active not recruiting No outcome recorded
Phase 1 NCT06045286 Sep 2023 → Sep 2024 metastasis from malignant tumor of colon Jiangsu Cancer Institute & Hospital Unknown No outcome recorded
Phase 1 NCT05536141 Oct 2022 → Mar 2029 expected clear cell renal carcinoma Arcus Biosciences, Inc. Recruiting No outcome recorded
Phase 1 NCT05007782 Aug 2021 → Dec 2028 expected neoplasm Gilead Sciences Recruiting No outcome recorded
Phase 1 NCT04999761 Jun 2021 → May 2026 overdue alveolar soft part sarcoma, biliary tract cancer, colorectal cancer, esophageal cancer +4 Taiho Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT04772989 Mar 2021 → Aug 2025 cervical cancer, diffuse large B-cell lymphoma, esophageal cancer, gastric cancer +4 Arcus Biosciences, Inc. Completed No outcome recorded
Phase 1 NCT04104672 Nov 2019 → May 2027 expected malignant exocrine pancreas neoplasm Arcus Biosciences, Inc. Active not recruiting No outcome recorded
Phase 1/28 trials
Phase 1/2 NCT06238921 Dec 2024 → Feb 2027 expected triple-negative breast carcinoma H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1/2 NCT05978401 Aug 2023 → Apr 2025 non-small cell lung carcinoma Guangzhou Gloria Biosciences Co., Ltd. Unknown No outcome recorded
Phase 1/2 NCT05688215 Mar 2023 → Dec 2026 expected pancreatic ductal adenocarcinoma Jonsson Comprehensive Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT05759312 Mar 2023 → Feb 2025 ovarian clear cell cancer Fudan University Unknown No outcome recorded
Phase 1/2 NCT05419479 Nov 2022 → May 2026 pancreatic adenocarcinoma, pancreatic adenosquamous carcinoma James Cleary, MD, PhD Suspended No outcome recorded
Phase 1/2 NCT05909436 Oct 2022 → Dec 2026 expected cancer Guangzhou Gloria Biosciences Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT04660812 May 2021 → Sep 2025 colorectal cancer Arcus Biosciences, Inc. Completed No outcome recorded
Phase 1/2 NCT04381832 Jul 2020 → Aug 2024 castration-resistant prostate carcinoma Arcus Biosciences, Inc. Completed No outcome recorded
Phase 238 trials
Phase 2 NCT07424664 Jun 2026 → Mar 2027 expected cervical cancer, vaginal neoplasm, vulva cancer Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting No outcome recorded
Phase 2 NCT07337447 Apr 2026 → Apr 2029 expected neuroendocrine carcinoma Hospices Civils de Lyon Not yet recruiting No outcome recorded
Phase 2 NCT07134556 Apr 2026 → May 2028 triple-negative breast carcinoma MedSIR Withdrawn No outcome recorded
Phase 2 NCT07397611 Mar 2026 → Jan 2028 expected renal cell carcinoma Dana-Farber Cancer Institute Recruiting No outcome recorded
Phase 2 NCT07283848 Feb → Dec 2026 gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Massachusetts General Hospital Withdrawn No outcome recorded
Phase 2 NCT06790706 Oct 2025 → Nov 2028 expected carcinoid tumor, digestive system neuroendocrine neoplasm, gestational trophoblastic neoplasm, peritoneal mesothelioma +2 Hospices Civils de Lyon Active not recruiting No outcome recorded
Phase 2 NCT06250036 Feb 2025 → Mar 2027 expected gastric adenocarcinoma, gastroesophageal junction adenocarcinoma Royal Marsden NHS Foundation Trust Recruiting No outcome recorded
Phase 2 NCT06133517 Jan 2025 → Jan 2030 expected infiltrating bladder urothelial carcinoma Fundación para el Progreso de la Oncología en Cantabria Active not recruiting No outcome recorded
Phase 2 NCT06528483 Dec 2024 → Dec 2026 expected infiltrating bladder urothelial carcinoma Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Not yet recruiting No outcome recorded
Phase 2 NCT06048484 May 2024 → Apr 2027 expected pancreatic ductal adenocarcinoma Gulam Manji Recruiting No outcome recorded
Phase 36 trials
Phase 3 NCT07710885 Jun 2026 → Apr 2030 expected biliary tract cancer Taiho Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06431633 Feb 2025 → Nov 2031 expected non-small cell lung carcinoma Fundación GECP Recruiting No outcome recorded
Phase 3 NCT05798819 May 2023 → May 2025 overdue Guangzhou Gloria Biosciences Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT05568095 Nov 2022 → Jun 2026 overdue adenocarcinoma Arcus Biosciences, Inc. Active not recruiting No outcome recorded
Phase 3 NCT05502237 Oct 2022 → Jun 2028 expected non-small cell lung carcinoma Gilead Sciences Active not recruiting No outcome recorded
Phase 3 NCT05518318 Sep 2022 → Jun 2025 classic Hodgkin lymphoma Guangzhou Gloria Biosciences Co., Ltd. Unknown No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT07619313 Background Jun 2026 → Jun 2027 expected cholangiocarcinoma, pancreatic ductal adenocarcinoma Jonsson Comprehensive Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT05891171 Background Oct 2023 → Sep 2027 expected cancer of unknown primary site, cervical cancer, esophageal cancer, gastric cancer +7 Arcus Biosciences, Inc. Active not recruiting No outcome recorded
Phase 1 NCT05840224 Background May 2023 → Jul 2026 overdue cancer Gilead Sciences Active not recruiting No outcome recorded
Phase 1 NCT04747470 Background Mar 2021 → Nov 2022 cancer Gilead Sciences Terminated No outcome recorded
Phase 22 trials
Phase 2 NCT06727565 Background Feb 2025 → Aug 2026 overdue head and neck squamous cell carcinoma Gilead Sciences Active not recruiting No outcome recorded
Phase 2 NCT04854499 Comparator Sep 2021 → Oct 2024 head and neck squamous cell carcinoma Gilead Sciences Terminated No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2024-06-02 Gilead Sciences Gilead and Arcus Announce Etrumadenant Plus Zimberelimab Regimen Significantly Reduced the Risk of Death in Third-line Metastatic Colorectal Cancer gilead.com
2024-06-01 Gilead Sciences Gilead and Arcus Announce Anti-TIGIT Domvanalimab Plus Zimberelimab and Chemotherapy Exceeded One Year of Median Progression-Free Survival as a First-Line Treatment for Upper GI Cancers gilead.com

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 77 sources stand behind the page.

FieldValueCited text
Known as zimberelimab “Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.” PMID 37875323 Dec 2023
67

“Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.” NCT06045286

“GLS-010 (zimberelimab) is a novel, fully human, anti-programmed death-1 monoclonal antibody” PMID 34462189 Aug 2021

NCT06759649

NCT07619313

NCT04087018

NCT05335941

NCT06166589

NCT04747470

NCT06238921

NCT07337447

NCT05676931

NCT06727565

NCT05886634

NCT06082960

NCT05024097

NCT05724563

NCT05329766

NCT04660812

NCT05536141

NCT05915442

NCT06133517

NCT06048133

NCT05891171

NCT05419479

NCT05824468

NCT03846310

NCT04104672

NCT06128460

NCT05568095

NCT06009029

NCT04381832

NCT03629756

NCT06155396

NCT07283848

NCT05872724

NCT05840224

NCT06048484

NCT05437692

NCT04656535

NCT06790706

NCT05007782

NCT06250036

NCT07424664

NCT04772989

NCT06107114

NCT05759312

NCT05177770

NCT06528483

NCT05688215

NCT03628677

NCT04854499

NCT06055738

NCT03547973

NCT04892875

NCT05900765

NCT06532565

NCT04791839

NCT07397611

NCT05632848

NCT07134556

NCT04736173

NCT04262856

NCT05502237

NCT05130177

NCT05633667

NCT07710885

NCT06431633

Known as AB122 “Zimberelimab (AB122) is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets PD-1.” NCT04656535
4

“* Zimberelimab (also known as AB122)” NCT05419479

“Drug: Zimberelimab (AB122)” NCT07134556

“Zimberelimab (AB122)” NCT05024097

NCT04999761

Known as GLS-010 “In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined.” NCT05909436
7

“Zimberelimab (GLS-010),240mg d1 iv Q21D” NCT06009029

NCT05798819

NCT05978401

NCT03713905

NCT03972722

NCT05518318

NCT03655483

Known as ZIM Zimberelimab (ZIM) + Chemotherapy” NCT05502237
Action Inhibit “Zimberelimab is a fully human anti-PD-1 monoclonal antibody.” NCT03629756
Modality Monoclonal antibody “Zimberelimab is a fully human anti-PD-1 monoclonal antibody.” NCT03629756
Route Intravenous “Administered intravenously” NCT03547973
Target PDCD1 “can specially block the PD-1/PD-L1/2 axis” PMID 33691262 Mar 2021