Spots Global Cancer Trial Database for Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
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Trial Identification
Brief Title: Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Official Title: An Open-Label Phase Ib/II Study of Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Study ID: NCT04579757
Study Description
Brief Summary: This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2).
Detailed Description: This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2). Part 1 will be conducted to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to standard therapies. Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors. Patients will receive the RP2D determined in part 1 of this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Oncology Associated, PC-HOPE, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
Rocky Mountain Cancer Centers Midtown, Denver, Colorado, United States
Johns Hopkins University - Sibley Memorial Hospital, Washington, District of Columbia, United States
Emory University - Winship Cancer Institute, Atlanta, Georgia, United States
Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
University of Pennsylvania, Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States
Prisma Health - Upstate (ITOR), Greenville, South Carolina, United States
Sarah Cannon, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology, P.A., Fort Worth, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology, P.A., Tyler, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Contact Details
Name: John Kauh, MD
Affiliation: Hutchmed
Role: STUDY_CHAIR
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