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Brief Title: Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors
Official Title: An Open-Label, Multicenter, Phase 1a Study of AN2025 and AN0025 in Double Combination With Atezolizumab and in Triple Combination With Atezolizumab in Patients With Advanced Solid Tumors
Study ID: NCT04975958
Brief Summary: This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors.
Detailed Description: This is an open-label, multicenter, Phase 1a study to evaluate the safety, tolerability, PK and preliminary efficacy of AN2025 and AN0025 in double or triple combination treatments with Atezolizumab in patients with locally advanced/metastatic tumors. This study consists of three DLT Observation Periods I, II and III. Observations I and II are double combination treatments, which will be conducted in parallel, whereas Observation III (the triple combination treatment) will be initiated only after a thorough review of the safety data from Observations I and II. In all three Observation Periods, a "6 + 3 design" will be utilized for dose finding with dose escalation and de-escalation.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Colorado Cancer Center, Aurora, Colorado, United States
Florida Cancer Specialists - Lake Mary Cancer Center, Lake Mary, Florida, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
NYU Grossman School of Medicine, New York, New York, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Name: Robert Atkinson, PhD, MSCR
Affiliation: Adlai Nortye US Inc
Role: STUDY_DIRECTOR