Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.

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

Details

• Lead Sponsor: Arcus Biosciences, Inc.
• Treatments: Carboplatin; Fluorouracil; Leucovorin; Oxaliplatin; Pemetrexed

Criteria

Key Inclusion Criteria:

• Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance

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

• Monotherapy-specific criteria for dose escalation cohorts:

• Participants may have pathologically confirmed NSCLC, gastric/GEJ, esophageal, HNSCC, bladder, RCC, TNBC, cervical, and ovarian cancers for which standard therapy has proven ineffective, intolerable, or considered inappropriate

• Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):

• Histologically confirmed, documented diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC

• Treatment-naive in the unresectable locally advanced or metastatic setting

• Cannot have progressed within 6 months of prior platinum-based chemotherapy

• Mixed small-cell lung cancer histology is not permitted

• Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):

• Histologically confirmed, documented diagnosis of human epidermal growth factor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma

• No prior systemic treatment for locally advanced unresectable or metastatic disease

• Cannot have progressed within 6 months of prior platinum-based chemotherapy

Key Exclusion Criteria:

• Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study

• Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion, will make the administration of the study drugs hazardous

• Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment

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

• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions

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