Spots Global Cancer Trial Database for AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
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Trial Identification
Brief Title: AN0025 and Pembrolizumab Combination in Advanced Solid Tumors
Official Title: An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Study ID: NCT04432857
Study Description
Brief Summary: This is an open-label, multicenter, phase Ib study to evaluate the safety and preliminary efficacy of AN0025 in combination with pembrolizumab in patients with locally advanced/metastatic tumors. It will include a dose-limiting toxicity observation phase followed by an expansion phase. All enrolled patients will be treated with AN0025 and Pembrolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent, or for a maximum of 35 cycles (approximately 2 years). The dose of pembrolizumab will remain constant at 200 mg every 3 weeks (Q3W) for each dose level of AN0025 and in each cohort.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah School of Medicine Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Virginia, Richmond, Virginia, United States
Centre Léon Bérard, Lyon, , France
Gustave Roussy, Paris, , France
Contact Details
Name: Robert Atkinson, Ph.D.
Affiliation: Adlai Nortye US Inc
Role: STUDY_DIRECTOR
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