Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers (ARC-25)
Advanced Cancer, Advanced Malignancies, Bladder Cancer
About this trial
This is an interventional treatment trial for Advanced Cancer focused on measuring AB598, AB122, Zimberelimab
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 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.
Sites / Locations
- Affinity Health-Hope and Healing Cancer Services, LLCRecruiting
- Gabrail Cancer CenterRecruiting
- Next Oncology DallasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Dose Escalation Cohort 1
Dose Escalation Cohort 2
Dose Escalation Cohort 3
Dose Escalation Cohort 4
Dose Expansion Cohort 1 NSCLC
Dose Expansion Cohort 2 Gastric/GEJ Cancer
Participants will receive AB598 intravenous (IV) infusion once every 3 weeks
Participants will receive AB598 IV infusion once every 3 weeks
Participants will receive AB598 IV infusion once every 3 weeks
Participants will receive AB598 IV infusion once every 3 weeks
Participants will receive AB598 IV infusion in combination with zimberelimab and carboplatin/pemetrexed once every 3 weeks, for up to 2 years
Participants will receive AB598 IV infusion in combination with zimberelimab once every 3 weeks, and FOLFOX (oxaliplatin, leucovorin, fluorouracil) every 2 weeks, for up to 2 years