Domvanalimab

Phase 3Monoclonal antibody

Domvanalimab is a monoclonal antibody that works as a T-Cell Immunoreceptor With Ig and ITIM Domains Inhibitor.[2] It is being investigated across 11 indications, with its most advanced program in Phase 3.[1]

Domvanalimab is one of 296 small molecule programs targeting Peritoneal Mesothelioma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

295

Competitors

Pipeline

Status by Indication[3][1]

Indication

Peritoneal MesotheliomaActive, not recruiting

Gastrointestinal Tract MalignanciesActive, not recruiting

Hepatobiliary CancerActive, not recruiting

Metastatic Urothelial CancerActive, not recruiting

Safety and EfficacyNot yet recruiting

MelanomaRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Lung CancerActive, not recruiting

Bladder CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

Peritoneal MesotheliomaPhase 2

Active, not recruiting

Gastrointestinal Tract MalignanciesPhase 2

Active, not recruiting

Hepatobiliary CancerPhase 2

Active, not recruiting

Metastatic Urothelial CancerPhase 2

Active, not recruiting

Safety and EfficacyPhase 2

Not yet recruiting

MelanomaPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Lung CancerPhase 2

Active, not recruiting

Bladder CancerPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Domvanalimab

Arcus Biosciences

Phase 3

5 2

Neoadjuvant Therapy

SSun Yat-sen University

Phase 3

2 3

WX-0593

Qilu Pharmaceutical Co., Ltd.

Phase 3

4 4

Remeron

OOrganon and Co

Preclinical

1 5

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 6

Vibramycin

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

Treatment

1 8

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—9

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

PD-1 Inhibitors

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 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06727565

Q2 2027

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT04736173

Phase 2Active, not recruiting

Gastrointestinal Tract Malignancies

NCT05329766

Q3 2027

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT05211895

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

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

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

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

Show 2 more trials

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

Active, not recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT04736173·169 enrolled

A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05211895·791 enrolled

Lung Cancer2 trials

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT05676931·400 enrolled

Study of Novel Treatment Combinations in Patients With Lung Cancer

Recruiting· Gilead logo

Gilead·Phase 2·NCT05633667·270 enrolled

Glioblastoma1 trial

AB154 Combined With AB122 for Recurrent Glioblastoma

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

Pancreatic1 trial

Switch Maintenance in Pancreatic

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

Esophageal Adenocarcinoma1 trial

Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT07283848

10 more indications

Melanoma1 trial

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

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

Advanced Malignancies1 trial

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

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

Bladder Cancer1 trial

PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer

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

Head and Neck Squamous Cell Carcinoma1 trial

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

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

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)

Active, not recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT05329766·332 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

Peritoneal Mesothelioma1 trial

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

Active, not recruiting·HHospices Civils de Lyon·Phase 2·NCT06790706·27 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Domvanalimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Domvanalimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Domvanalimab. 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: T-Cell Immunoreceptor With Ig and ITIM Domains Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Arcus Biosciences

Domvanalimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Lung Cancer2 trials

Glioblastoma1 trial

Pancreatic1 trial

Esophageal Adenocarcinoma1 trial

Melanoma1 trial

Advanced Malignancies1 trial

Safety and Efficacy1 trial

Bladder Cancer1 trial

Gastrointestinal1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Metastatic Urothelial Cancer1 trial

Gastrointestinal Tract Malignancies1 trial

Hepatobiliary Cancer1 trial

Peritoneal Mesothelioma1 trial

References

Drug Info

Quick Facts

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