Domvanalimab for Gastrointestinal Tract Malignancies

Phase-Based Progress Estimates

Effectiveness

Safety

Gastrointestinal Tract Malignancies+1 More

Domvanalimab - Drug

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Eligibility

18+

All Sexes

What conditions do you have?

Select

Eligibility

18+

All Sexes

What conditions do you have?

Select

Study Summary

This trial will test the safety and effectiveness of two different immunotherapy drugs, either alone or in combination with chemotherapy, for people with esophageal or stomach cancer that has spread and can't be removed with surgery.

Eligible Conditions

Gastrointestinal Tract Malignancies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Gastrointestinal Tract Malignancies

PFK-158

Domvanalimab

Bevacizumab

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 18 months

Month 18

Overall survival

Up to 18 months

Disease Control (complete response, partial response, or stable disease) for greater than equal to 12 weeks

Duration of response (DOR) as determined by the Investigator according to RECIST v1.1

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Objective Response Rate as measured by PD-L1 Expression Level

Objective Response Rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Percentage of participants with anti-drug antibodies to domvanalimab

Percentage of participants with anti-drug antibodies to zimberelimab

Plasma concentration of domvanalimab

Plasma concentration of zimberelimab

Progression-free survival (PFS) as determined by the Investigator according to RECIST v1.1

Trial Safety

Safety Progress

2 of 3

This is further along than 68% of similar trials

Other trials for Gastrointestinal Tract Malignancies

PFK-158

Domvanalimab

Bevacizumab

Trial Design

3 Treatment Groups

Cohort C: Second Line or greater - Checkpoint Inhibitor Experienced Participants

1 of 3

Cohort B: Second Line or greater Checkpoint Inhibitor Naïve Participants

1 of 3

Cohort A: First Line - Treatment Naïve Participants

1 of 3

Experimental Treatment

120 Total Participants · 3 Treatment Groups

Primary Treatment: Domvanalimab · No Placebo Group · Phase 2

Cohort C: Second Line or greater - Checkpoint Inhibitor Experienced ParticipantsExperimental Group · 2 Interventions: Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug

Cohort B: Second Line or greater Checkpoint Inhibitor Naïve ParticipantsExperimental Group · 2 Interventions: Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug

Cohort A: First Line - Treatment Naïve ParticipantsExperimental Group · 5 Interventions: Fluorouracil, Leucovorin, Oxaliplatin, Zimberelimab, Domvanalimab · Intervention Types: Drug, Drug, Drug, Drug, Drug

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluorouracil

2014

Completed Phase 3

~11290

Leucovorin

2014

Completed Phase 4

~5460

Oxaliplatin

2003

Completed Phase 4

~4430

Zimberelimab

2018

Completed Phase 1

~50

Trial Logistics

Trial Timeline

Approximate Timeline

Screening: ~3 weeks

Treatment: Varies

Reporting: up to 18 months

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor

1,006 Previous Clinical Trials

653,269 Total Patients Enrolled

Arcus Biosciences, Inc.Lead Sponsor

29 Previous Clinical Trials

5,179 Total Patients Enrolled

Medical DirectorStudy DirectorArcus Biosciences, Inc.

2,618 Previous Clinical Trials

7,936,705 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

You have at least one target lesion per RECIST v1.1.

You have adequate organ and marrow function.

About The Reviewer

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References