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

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Arcus Biosciences, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.

Eligibility Criteria

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.

Inclusion Criteria

My organs and bone marrow are working well.

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

I can sign and follow the study's consent form and rules.

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Exclusion Criteria

I have not needed treatment for an autoimmune disease in the last 3 years.

I stopped immunotherapy due to severe side effects.

I have not had major surgery or serious injury in the last 28 days.

See 2 more

Treatment Details

Interventions

AB308 (Monoclonal Antibodies)
Zimberelimab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.