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Brief Title: First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors
Official Title: A Phase 1/1B First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Patients With Advanced Solid Tumors
Study ID: NCT04528836
Brief Summary: A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.
Detailed Description: The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope, Duarte, California, United States
Scripps MD Anderson Cancer Center, La Jolla, California, United States
UC Irvine Health, Orange, California, United States
UCLA Hematology/Oncology - Santa Monica, Santa Monica, California, United States
Sarah Cannon Research Institute, Denver, Colorado, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
NEXT Virginia, Fairfax, Virginia, United States
MultiCare Institute for Research & Innovation, Tacoma, Washington, United States