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Spots Global Cancer Trial Database for Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Robert Atkinson, PhD, MSCR

Affiliation: Adlai Nortye US Inc

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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