Zimberelimab

Phase 3Monoclonal antibody

Zimberelimab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Inhibitor.[2] It is being investigated across 24 indications, with its most advanced program in Phase 3.[1]

Zimberelimab is one of 621 small molecule programs targeting Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

620

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung CancerRecruiting

LymphomaRecruiting

Pancreatic Ductal AdenocarcinomaRecruiting

Biliary Tract CancerRecruiting

Metastatic Prostate CancerRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerRecruiting

MelanomaRecruiting

Pancreatic CancerNot yet recruiting

Head and Neck Squamous Cell CarcinomaUnknown status

Lung CancerPhase 3

Recruiting

LymphomaPhase 2

Recruiting

Pancreatic Ductal AdenocarcinomaPhase 2

Recruiting

Biliary Tract CancerPhase 3

Recruiting

Metastatic Prostate CancerPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Breast CancerPhase 2

Recruiting

MelanomaPhase 2

Recruiting

Pancreatic CancerPhase 2

Not yet recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Unknown status

Showing 10 of 23 indications

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zimberelimab

Arcus Biosciences

Phase 3

1 2

Zolymbus

AbbVie

Preclinical

1 3

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 4

Duragesic-100

CCephalon

Preclinical

2 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 6

Tricor

JJagotec

Preclinical

1 7

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 8

Vfend

PPrism Pharmaceuticals

Rilvegostomig

1 10

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Glioblastoma

NCT04656535

Q1 2027

Phase 2Not yet recruiting

Pancreatic Cancer

NCT06166589

Phase 1/2Recruiting

Breast Cancer

NCT06238921

Phase 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06727565

PreclinicalRecruiting

Borderline Resectable Pancreatic Adenocarcinoma

NCT05688215

Q2 2027

Phase 2Recruiting

Pancreatic Ductal Adenocarcinoma

NCT06048484

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 3·NCT05502237·1,021 enrolled

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

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT04791839·30 enrolled

Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT04262856·151 enrolled

Show 1 more trial

Official Title: A Phase 2 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT04736173·169 enrolled

Lung Cancer4 trials

Study of Novel Treatment Combinations in Patients With Lung Cancer

Recruiting· Gilead logo

Gilead·Phase 2·NCT05633667·270 enrolled

Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.

Recruiting·FFundación GECP·Phase 3·NCT06431633·129 enrolled

A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT03846310·77 enrolled

Show 1 more trial

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT05676931·400 enrolled

Advanced Solid Tumors3 trials

Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT04087018·18 enrolled

Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

Recruiting· Gilead logo

Gilead·Phase 1·NCT06532565·154 enrolled

Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors

Terminated· Gilead logo

Gilead·Phase 1·NCT04747470·13 enrolled

Advanced Malignancies3 trials

A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT03629756·48 enrolled

A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT03628677·75 enrolled

A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT04772989·94 enrolled

Cervical Cancer3 trials

Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.

Not yet recruiting·OObstetrics & Gynecology Hospital of Fudan University·Phase 2·NCT06128460·24 enrolled

Zimberelimab Plus Lenvatinib After Progression on Prior Immune Checkpoint Inhibitors for Advanced Cervical Cancer

Active, not recruiting·SSun Yat-sen University·Phase 2·NCT05824468·30 enrolled

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06155396·116 enrolled

34 more indications

Head and Neck Squamous Cell Carcinoma3 trials

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Terminated· Gilead logo

Gilead·Phase 2·NCT04854499·193 enrolled

Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcinoma

Unknown status·XXuekui Liu·Phase 2·NCT06107114·52 enrolled

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

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06727565·39 enrolled

Pancreatic Cancer2 trials

SBRT Combined With Zimberelimab (GLS-010) in Locally Advanced Pancreatic Cancer (SPARK-1 Study)

Not yet recruiting·PPeking University Third Hospital·Phase 2·NCT06009029·96 enrolled

Second-line Zimberelimab and SIRIOX Chemotherapy for Patient With Previously AG Chemotherapy Treated Pancreatic Cancer

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06166589·19 enrolled

Pancreatic Ductal Adenocarcinoma2 trials

Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma

Recruiting·GGulam Manji·Phase 2·NCT06048484·60 enrolled

A Phase 1/1b Trial of AB801 in Combination With Chemotherapy and PD-1/PD-L1 Blockade in Patients With Cholangiocarcinoma or Pancreatic Adenocarcinoma

Recruiting·JJonsson Comprehensive Cancer Center·Phase 1·NCT07619313·46 enrolled

Prostate Cancer2 trials

Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1/2·NCT04381832·173 enrolled

Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer

Terminated·CCoherus Oncology, Inc.·Phase 2·NCT05177770·16 enrolled

Solid Tumor2 trials

A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Active, not recruiting· Gilead logo

Gilead·Phase 1·NCT05007782·304 enrolled

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

Active, not recruiting· Gilead logo

Gilead·Phase 1·NCT05840224·182 enrolled

Metastatic Colorectal Cancer1 trial

An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer.

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1/2·NCT04660812·227 enrolled

Safety and Efficacy1 trial

Phase II Trial Evaluating the Safety and Efficacy of the Combination of Zimberelimab, Domvanalimab and Sacituzumab Govitecan as 1L Therapy for PD-L1 Positive Advanced TNBC

Not yet recruiting·MMedSIR·Phase 2·NCT07134556·25 enrolled

Lymphoma1 trial

A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma

Recruiting·SSun Yat-sen University·Phase 2·NCT05900765·54 enrolled

Immunotherapy1 trial

Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC

Recruiting·—·Phase 2·NCT07397611·32 enrolled

Glioblastoma1 trial

AB154 Combined With AB122 for Recurrent Glioblastoma

Active, not recruiting·YYale University·Phase 1·NCT04656535·46 enrolled

Neoadjuvant Treatment1 trial

Zimberelimab Combined With Albumin-bound Paclitaxel and Cisplatin in Neoadjuvant Treatment of LACC

Recruiting·TTang-Du Hospital·Phase 2·NCT06055738·20 enrolled

Metastatic Prostate Cancer1 trial

Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer

Recruiting·CCatherine Spina·Phase 2·NCT05915442·23 enrolled

Solid Tumors1 trial

Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

Active, not recruiting· Gilead logo

Gilead·Phase 1·NCT06082960·45 enrolled

Melanoma1 trial

Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma

Recruiting·DDiwakar Davar·Phase 2·NCT05130177·26 enrolled

Pancreatic1 trial

Switch Maintenance in Pancreatic

Suspended·—·Phase 1/2·NCT05419479·46 enrolled

Ovarian Clear Cell Carcinoma1 trial

Zimberelimab Plus Metformin for Recurrent Ovarian Clear Cell Carcinoma

Unknown status·FFudan University·Phase 1/2·NCT05759312·20 enrolled

Breast Cancer1 trial

Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT06238921·31 enrolled

Locally Advanced Head and Neck Cancer1 trial

A Study of Concurrent Chemoradiation in Combination With or Without PD1 Inhibitor AB122 Adenosine 2a Receptor / Adenosine 2b Receptor Inhibitor AB928 Therapies in Locally Advanced Head and Neck Cancers

Withdrawn·JJennifer Choe·Phase 1·NCT04892875

Esophageal Adenocarcinoma1 trial

Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT07283848

Clear Cell Renal Cell Carcinoma1 trial

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

Recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05536141·362 enrolled

Advanced Cancer1 trial

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

Active, not recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT05891171·40 enrolled

Borderline Resectable Pancreatic Adenocarcinoma1 trial

A Pilot Study of Zimberelimab and Quemliclustat Combination With Chemotherapy in Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Recruiting·JJonsson Comprehensive Cancer Center·Preclinical·NCT05688215·56 enrolled

Gastrointestinal Tract Malignancies1 trial

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

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT05329766·332 enrolled

Dedifferentiated Liposarcoma1 trial

A Phase II Study of Adenosine Receptor (A2A and A2B) Inhibition (AB928) in Combination With Anti-PD-1 Therapy (AB122) in Patients With Advanced Dedifferentiated Liposarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05886634·16 enrolled

Urinary Bladder Cancer1 trial

An Open Label, Single-arm, Phase 2 Study of Perioperative Sacituzumab Govitecan in Combination With Zimberelimab and Domvanalimab for Patients With Muscle Invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy

Active, not recruiting·FFundación para el Progreso de la Oncología en Cantabria·Phase 2·NCT06133517·70 enrolled

Advanced Pancreatic Cancer1 trial

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

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT04104672·196 enrolled

Gastrointestinal1 trial

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

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 3·NCT05568095·1,040 enrolled

Metastatic Urothelial Cancer1 trial

A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT03547973·502 enrolled

Biliary Tract Carcinoma1 trial

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

Active, not recruiting·NNataliya Uboha·Phase 2·NCT06048133·33 enrolled

Urothelial Carcinoma1 trial

A Phase 2 Study to Evaluate the Triplet Combination of Pemetrexed Plus AB928 (Etrumadenant) + AB122 (Zimberelimab) in Patients With Previously Treated Advanced or Metastatic MTAP Deficient Urothelial Carcinoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05335941·10 enrolled

Neoplasm1 trial

A First-in-Human, Phase 1 Dose Escalation and Dose Expansion Trial to Assess the Safety and Tolerability of COM503 as Monotherapy and in Combination Therapy in Participants With Advanced Solid Malignancies

Recruiting·CCompugen Ltd·Phase 1·NCT06759649·200 enrolled

Rectal Cancer1 trial

A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer.

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT05024097·43 enrolled

Biliary Tract Cancer1 trial

A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Recruiting· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT07710885·784 enrolled

Hepatobiliary Cancer1 trial

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

Active, not recruiting·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT05724563·58 enrolled

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Zimberelimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Zimberelimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Zimberelimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Arcus Biosciences company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Arcus Biosciences

Zimberelimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer4 trials

Lung Cancer4 trials

Advanced Solid Tumors3 trials

Advanced Malignancies3 trials

Cervical Cancer3 trials

Head and Neck Squamous Cell Carcinoma3 trials

Pancreatic Cancer2 trials

Pancreatic Ductal Adenocarcinoma2 trials

Prostate Cancer2 trials

Solid Tumor2 trials

Metastatic Colorectal Cancer1 trial

Safety and Efficacy1 trial

Lymphoma1 trial

Immunotherapy1 trial

Glioblastoma1 trial

Neoadjuvant Treatment1 trial

Metastatic Prostate Cancer1 trial

Solid Tumors1 trial

Melanoma1 trial

Pancreatic1 trial

Ovarian Clear Cell Carcinoma1 trial

Breast Cancer1 trial

Locally Advanced Head and Neck Cancer1 trial

Esophageal Adenocarcinoma1 trial

Clear Cell Renal Cell Carcinoma1 trial

Advanced Cancer1 trial

Borderline Resectable Pancreatic Adenocarcinoma1 trial

Gastrointestinal Tract Malignancies1 trial

Dedifferentiated Liposarcoma1 trial

Urinary Bladder Cancer1 trial

Advanced Pancreatic Cancer1 trial

Gastrointestinal1 trial

Metastatic Urothelial Cancer1 trial

Biliary Tract Carcinoma1 trial

Urothelial Carcinoma1 trial

Neoplasm1 trial

Rectal Cancer1 trial

Biliary Tract Cancer1 trial

Hepatobiliary Cancer1 trial

References

Drug Info

Quick Facts

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