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Drug

Zimberelimab

In clinical development
ClassProgrammed cell death protein 1 inhibitorEmerging researchLate-stage development

Also known as Immunoglobulin g4(231-proline), anti-(human programmed cell death protein 1) (human monoclonal ab122 .gamma.4-chain), disulfide with human monoclonal ab122 .lambda.-chain, dimer.

RxNorm2615290ChEMBLCHEMBL4297856UNIIZBL7O904IL
1
Research papers
38
Active clinical trials
Programmed cell death protein 1
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

VELOCITY-HNSCC Substudy-01: A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-4528 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Clinical trial2026-07-27Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants With Gastrointestinal Malignancies

Clinical trial2026-07-02Results expected Q2 2027 · ClinicalTrials.gov

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Clinical trial2026-07-02Results expected Q1 2029 · ClinicalTrials.gov

A Phase 2 Trial to Evaluate the Safety and Efficacy of Combination Therapies in Patients With Advanced Upper Gastrointestinal Tract Malignancies (EDGE-Gastric)

Clinical trial2026-07-02Results expected Q1 2027 · ClinicalTrials.gov

Phase II Basket Trial of Domvanalimab (AB154) and Zimberelimab (AB122) in Advanced Hepatobiliary Cancers

Clinical trial2026-07-02Results expected Q4 2027 · ClinicalTrials.gov

A Multicenter, Single-arm, Prospective Study of SBRT Combined With Zimberelimab (GLS-010) in Patients With Locally Advanced Pancreatic Cancer (SPARK-1 Study)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

Clinical trial2026-07-01Results expected Q3 2027 · ClinicalTrials.gov

Study of Gemcitabine, Cisplatin, Quemliclustat (AB680) and Zimberelimab (AB122) During First-line Treatment of Advanced Biliary Tract Cancers (QUIC)

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Pilot Study to Evaluate the Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer

Clinical trial2026-06-08Results expected Q4 2026 · ClinicalTrials.gov

Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.

Research2023-12-04International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Zimberelimab
Aliases & brands
Immunoglobulin g4(231-proline), anti-(human programmed cell death protein 1) (human monoclonal ab122 .gamma.4-chain), disulfide with human monoclonal ab122 .lambda.-chain, dimer
RxNorm CUI
2615290
ChEMBL ID
CHEMBL4297856
UNII
ZBL7O904IL
Primary mechanism
Programmed cell death protein 1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Programmed cell death protein 1
PDCD1 · Q15116
INHIBITORProgrammed cell death protein 1 inhibitor

Clinical trials

56 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
56
registered trials across all phases
LATEST COMPLETION 2025
38
Active studies
18
Recruiting
3
Late-stage (III+)
8
Completed
10
Discontinued
PHASE DISTRIBUTIONn = 56
Early Phase 11Phase 116Phase 1 / 26Phase 230Phase 33

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IIIFundación GECPn=1292031

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

Active, not recruitingPH IIIKey trialGilead Sciencesn=1,0212029

A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants With Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma

Active, not recruitingPH IIIKey trialArcus Biosciences, Inc.n=1,0402026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

CompletedPH I/IIArcus Biosciences, Inc.n=2272025

A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

CompletedPH IArcus Biosciences, Inc.n=942025

A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer

CompletedPH IIArcus Biosciences, Inc.n=1512025

A Phase 1 Study to Evaluate the Safety and Tolerability of AB154 Monotherapy and Combination Therapy in Participants With Advanced Malignancies

CompletedPH IArcus Biosciences, Inc.n=752025

A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Lung Cancer

CompletedPH IArcus Biosciences, Inc.n=772024

A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating the Efficacy and Safety of AB928-Based Treatment Combinations in Patients With Metastatic Castrate Resistant Prostate Cancer

CompletedPH I/IIArcus Biosciences, Inc.n=1732024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023 · 20 cites
Recent papers

Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023 · 20 cites
Major research themes1
Uterine Cervical Neoplasms1
Journals, researchers & institutions
Top journals
  • International journal of gynecological cancer : official journal of the International Gynecological Cancer Society1
Leading researchers
  • Ai X1
  • Chang B1
  • Chen J1
  • Cheng H1
  • Gulina K1
  • Li L1
  • Li Y1
  • Liu H1
Leading institutions
free-text, unnormalised
  • Affiliated Hospital of Yangzhou University1
  • Beijing Cancer Hospital1
  • Cancer Hospital of the University of Chinese Academy of Sciences1
  • Chongqing University Cancer Hospital1
  • Fudan University Shanghai Cancer Center1
  • Gansu Provincial Academic Institute for Medical Research1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials