Spots Global Cancer Trial Database for A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
Official Title: An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Study ID: NCT04577963
Study Description
Brief Summary: This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase. * Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated) * Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve) * Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve) * Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Arizona, Phoenix, Arizona, United States
Highlands Oncology, Springdale, Arkansas, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
University of Colorado, Aurora, Colorado, United States
Florida Cancer Specialists - FCS South, Port Charlotte, Florida, United States
Florida Cancer Center North, Saint Petersburg, Florida, United States
Florida Cancer Specialists Panhandle, Tallahassee, Florida, United States
Florida Cancer Specialists - East (FCS East), West Palm Beach, Florida, United States
HOC AON Baton Rouge / Sarah Cannon, Baton Rouge, Louisiana, United States
Messino Cancer Center, Asheville, North Carolina, United States
Oklahoma University Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Women and Infants Hospital of Rhode Island, Providence, Rhode Island, United States
Tennessee Oncology-Chattanooga, Chattanooga, Tennessee, United States
Tennesse Oncology, Nashville, Tennessee, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: William Schelman, MD, PhD
Affiliation: Hutchison MediPharma International
Role: STUDY_DIRECTOR
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