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Monoclonal Antibodies

Domvanalimab + Zimberelimab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmation that an archival tissue sample is available and ≤ 6 months old; if not, a new biopsy of a tumor must be obtained
Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The measurable lesion must be outside of a radiation field if the participant received prior radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first dose date to date of death, up to 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and works well.

Who is the study for?
Adults with advanced solid tumors who can consent, have a performance status score of 0 or 1, and no standard therapy options left. They must not be pregnant, breastfeeding, or planning to conceive soon. Participants need a recent tumor sample for study entry and cannot have active autoimmune diseases or other serious health issues.Check my eligibility
What is being tested?
The trial is testing Domvanalimab alone and combined with Zimberelimab in patients with advanced solid malignancies. It's an early-phase study to check safety, how the body processes the drugs (PK/PD), and their effects on cancer.See study design
What are the potential side effects?
As this is a Phase 1 trial primarily assessing safety and tolerability, specific side effects are not listed but may include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation-related symptoms in various organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent biopsy or tissue sample taken within the last 6 months.
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I have at least one tumor that can be measured and it's not in an area treated with radiation.
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My organs and bone marrow are working well.
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My cancer has no standard treatment available.
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I am fully active or can carry out light work.
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I am able to understand and sign the consent form.
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I am 18 years old or older.
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I had major surgery with general anesthesia over 4 weeks ago.
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I stopped taking high doses of steroids or similar medicines more than 2 weeks ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first dose date to date of death, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to date of death, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0
Secondary outcome measures
AB154 Peak Plasma Concentration (Cmax)
Disease Control Rate
Domvanalimab Area Under the Plasma Concentration Versus Time Curve (AUC)
+9 more
Other outcome measures
Receptive aphasia (finding)
Domvanalimab Cytokines
Domvanalimab Gene Expression
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4WExperimental Treatment2 Interventions
Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab
Group II: Domvanalimab and Zimberelimab Q6W combination therapyExperimental Treatment2 Interventions
Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab
Group III: Domvanalimab MonotherapyExperimental Treatment1 Intervention
Varying Doses of domvanalimab Monotherapy
Group IV: Domvanalimab + zimberelimab Q4W Combination TherapyExperimental Treatment2 Interventions
Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab
Group V: Domvanalimab + zimberelimab Q3W Combination TherapyExperimental Treatment2 Interventions
Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab
Group VI: Domvanalimab + zimberelimab Q2W Combination TherapyExperimental Treatment2 Interventions
Varying Doses of domvanalimab in Combination With Varying Doses of zimberelimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,831 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,873 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,769 Previous Clinical Trials
8,062,125 Total Patients Enrolled

Media Library

Domvanalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03628677 — Phase 1
Solid Tumors Research Study Groups: Domvanalimab and Zimberelimab Q6W combination therapy, Domvanalimab + zimberelimab Q3W Combination Therapy, Domvanalimab Monotherapy, Domvanalimab + zimberelimab Q2W Combination Therapy, Domvanalimab + zimberelimab Q4W Combination Therapy, Fixed dose Domvanalimab Q3W or Q4W and Zimberelimab Q3W, Q4W
Solid Tumors Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT03628677 — Phase 1
Domvanalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03628677 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Domvanalimab been given regulatory approval by the FDA?

"Having only limited evidence for safety and efficacy, domvanalimab was judged to be a 1 on the scale of risk assessment."

Answered by AI

Are there numerous establishments currently conducting this experiment within the United States?

"The Angeles Clinic and Research Institute in Los Angeles, California, Carolina BioOncology Institute in Huntersville, North carolina, Medical Oncology Associates (also known as Summit Cancer Centers) located in Spokane Washington are enrolling subjects for this clinical study. Additionally 4 other sites across the country will serve to recruit participants."

Answered by AI

Is recruitment for this research project still ongoing?

"According to clinicaltrials.gov, the recruitment period for this medical trial has closed; it was initially published on September 12th 2018 and last updated October 17th 2022. However, there are currently 2383 other trials actively recruiting participants."

Answered by AI
~7 spots leftby Nov 2024