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Monoclonal Antibodies

AB308 + Zimberelimab for Advanced Cancers (ARC-12 Trial)

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

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Be older than 18 years old

Must not have

Discontinued prior immunotherapy for immune related adverse events with a high severity.

Prior treatment with an anti-TIGIT antibody.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy to see if it is safe and effective in treating advanced malignancies.

Who is the study for?

This trial is for adults with advanced malignancies like certain lymphomas, lung, stomach, esophageal cancers and more. Participants must be able to consent, have an ECOG score of 0 or 1 indicating they are fully active or restricted in physically strenuous activity but ambulatory, and have proper organ/marrow function. They should not have had severe reactions to past immunotherapies or recent surgeries and must agree to use contraception.

What is being tested?

The study tests AB308 combined with Zimberelimab (AB122) on patients with advanced cancers. It's a Phase 1/1b trial that gradually increases doses to assess safety, how the body processes the drugs (PK), their effects on the body (PD), and their effectiveness against tumors.

What are the potential side effects?

While specific side effects aren't listed here, typical ones for cancer treatments like these may include fatigue, nausea, immune-related reactions such as inflammation in different parts of the body including skin rashes or liver issues; infusion-related reactions; changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I stopped immunotherapy due to severe side effects.

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I have been treated with an anti-TIGIT antibody before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Dose Expansion Cohort 5Experimental Treatment2 Interventions

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.

Group II: Dose Expansion Cohort 4Experimental Treatment2 Interventions

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.

Group III: Dose Expansion Cohort 3Experimental Treatment2 Interventions

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.

Group IV: Dose Expansion Cohort 2Experimental Treatment2 Interventions

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.

Group V: Dose Expansion Cohort 1Experimental Treatment2 Interventions

AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.

Group VI: Dose Escalation Q6W CohortExperimental Treatment2 Interventions

Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.

Group VII: Dose Escalation Q4W CohortsExperimental Treatment2 Interventions

Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.

Group VIII: Dose Escalation Q3W CohortsExperimental Treatment2 Interventions

Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2020