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Brief Title: Study of AGEN1571 in Participants With Advanced Solid Tumors
Official Title: A Phase 1 Study Investigating AGEN1571 as a Single Agent and in Combination With a PD-1 Inhibitor and/or Botensilimab (AGEN1181) in Patients With Advanced Solid Tumors
Study ID: NCT05377528
Brief Summary: This is an open-label, Phase 1, 2-part trial to determine recommended phase 2 doses (RP2Ds) and evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of AGEN1571 both as a monotherapy and in combination with balstilimab (PD-1 inhibitor) and/or botensilimab (2-agent combination or 3-agent combination) in participants diagnosed with advanced solid tumors. Part 1 will be the dose escalation phase to determine the RP2D of AGEN1571 monotherapy or AGEN1571 in combination with balstilimab and/or botensilimab. Part 2 will be the dose expansion phase for specific disease indications. Participants will receive study treatment for up to 2 years, or until any disease progression, unacceptable toxicity, or participant wishes to withdraw consent for any reason.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Lifespan Cancer Institute, Providence, Rhode Island, United States