A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcus Biosciences, Inc.

Criteria

• Performance status score of 0 or 1

• Measurable disease as per radiographic evaluation

• Disease-specific criteria for dose escalation:

• Participants with any type of solid tumor for which no treatment is currently available, or

• Participants with non-Hodgkin Lymphoma that has progressed on prior chemotherapy and have not or are unable to receive stem cell transplant. transfer

• Participants may have received up to 5 prior anti-cancer therapies and an unlimited number of prior hormonal therapies.

• Disease-specific criteria for dose-expansion Cohort 1:

• Participants with previously untreated locally advanced or metastatic NSCLC with a high PD-L1 expression

• Disease-specific criteria for dose-expansion Cohort 2:

• Participants with metastatic melanoma with at least one prior anti-cancer therapy and progression after PD-L1 therapy

• Disease-specific criteria for dose-expansion Cohort 3:

• Participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.

• Disease-specific criteria for dose-expansion Cohort 4:

• Participants with metastatic cervical cancer with at least 1 prior chemotherapy and no prior PD-(L)1 therapy.

• Disease-specific criteria for dose-expansion Cohort 5

• Participants with diffuse large B-cell lymphoma (DLBCL) with at least 2 prior anti-cancer therapies and have not or are unable to receive allogenic stem cell transplant

• Participants with multiple myeloma with at least 3 prior anti-cancer therapies and for whom no treatment is currently available.

Exclusion Criteria:

• History of trauma or major surgery within 28 days prior to the first dose of study treatment.

• Prior treatment with an anti-TIGIT antibody.

• Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.

• Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.

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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.