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

Launched by ARCUS BIOSCIENCES, INC. · May 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AB598 for patients with advanced cancers, including types like bladder, cervical, lung, and breast cancer, among others. The main goal is to see how safe AB598 is when used alone or combined with another drug called zimberelimab and standard chemotherapy. The trial is currently looking for participants aged 65 and older who have measurable cancer that hasn't responded well to other treatments.

To be eligible, patients must have a specific type of advanced cancer and a good performance status, meaning they can carry out daily activities with little to no assistance. Participants can expect to undergo regular check-ups to monitor their health and the effects of the treatment. It's important to note that certain medical conditions and recent treatments may exclude someone from participating, so potential candidates should discuss their individual health situations with their doctors. This trial is an opportunity to explore new treatment options that could be beneficial for patients with advanced cancer.

Gender

ALL

Eligibility 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
• • Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.
• * Monotherapy-specific criteria for dose escalation and PD cohorts:
• • Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
• • Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
• * Dose Expansion cohort criteria:
• • Histologically confirmed, documented diagnosis of 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 for earlier stage disease.
• 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 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.