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 13 indications, with its most advanced program in Phase 3.[1]

Domvanalimab is one of 334 small molecule programs targeting Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

333

Competitors

Pipeline

Status by Indication[3][1]

Indication

Lung CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Liver CancerActive, not recruiting

Esophageal AdenocarcinomaActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

MelanomaActive, not recruiting

Bladder CancerActive, not recruiting

Head and Neck Squamous Cell CarcinomaActive, not recruiting

GlioblastomaActive, not recruiting

Peritoneal MesotheliomaActive, not recruiting

Lung CancerPhase 2

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Liver CancerPhase 2

Active, not recruiting

Esophageal AdenocarcinomaPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Bladder CancerPhase 2

Active, not recruiting

Head and Neck Squamous Cell CarcinomaPhase 2

Active, not recruiting

GlioblastomaPhase 1

Active, not recruiting

Peritoneal MesotheliomaPhase 2

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Domvanalimab

Arcus Biosciences

Phase 3

3 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

Lenvima

Eisai

Preclinical

6 4

Imjudo

AstraZeneca

Preclinical

5 5

Vizimpro

Pfizer

Preclinical

4 6

Ofev

Boehringer Ingelheim

Preclinical

7 7

Remeron

OOrganon and Co

Preclinical

1 8

REGN2810

Regeneron

Preclinical

1 9

Vibramycin

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

Treatment

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Head and Neck Squamous Cell Carcinoma

NCT06727565

Q4 2026

Phase 1Active, not recruiting

Glioblastoma

NCT04656535

Q2 2027

Phase 2Active, not recruiting

Lung Cancer

NCT04736173

Phase 2Active, not recruiting

Gastrointestinal Tract Malignancies

NCT05329766

Q4 2027

Phase 2Active, not recruiting

Lung Cancer

NCT05676931

Clinical

Trials by Indication[1]

Lung Cancer3 trials

Study of Novel Treatment Combinations in Patients With Lung Cancer

Recruiting· Gilead logo

Gilead·Phase 2·NCT05633667·270 enrolled

Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer

Active, not recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 2·NCT04736173·169 enrolled

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT05676931·400 enrolled

Non-Small Cell Lung Cancer3 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

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

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

Gastrointestinal1 trial

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

Active, not recruiting· Arcus Biosciences logo

Arcus Biosciences·Phase 3·NCT05568095·1,040 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

11 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

Head and Neck Squamous Cell Carcinoma1 trial

Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01

Active, not recruiting· Gilead logo

Gilead·Phase 2·NCT06727565·100 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

Pancreatic1 trial

Switch Maintenance in Pancreatic

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

Resectable NSCLC1 trial

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05211895·860 enrolled

Esophageal Adenocarcinoma1 trial

Zimberelimab + Domvanalimab in Gastroesophageal Adenocarcinoma

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT07283848

Urothelial Cancer1 trial

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

Recruiting· Gilead logo

Gilead·Phase 2·NCT03547973·827 enrolled

Glioblastoma1 trial

AB154 Combined With AB122 for Recurrent Glioblastoma

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

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

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

Q3 2026

Q4 2026

Q2 2027

Q4 2027

Trials by Indication[1]

Lung Cancer3 trials

Non-Small Cell Lung Cancer3 trials

Safety and Efficacy1 trial

Gastrointestinal1 trial

Bladder Cancer1 trial

Melanoma1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Advanced Malignancies1 trial

Pancreatic1 trial

Resectable NSCLC1 trial

Esophageal Adenocarcinoma1 trial

Urothelial Cancer1 trial

Glioblastoma1 trial

Hepatobiliary Cancer1 trial

Gastrointestinal Tract Malignancies1 trial

Peritoneal Mesothelioma1 trial

References

Drug Info

Quick Facts

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