Spots Global Cancer Trial Database for (Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
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Trial Identification
Brief Title: (Concerto) Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Official Title: Phase I/II Study of BLU-451 in Advanced Cancers With EGFR Exon 20 Insertion Mutations
Study ID: NCT05241873
Conditions
Study Description
Brief Summary: This is a Phase 1/2, open-label first-in-human study of the safety, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLU-451 monotherapy and BLU-451 in combination with platinum-based chemotherapy (carboplatin and pemetrexed). All participants will receive BLU-451 on a 21-day treatment cycle.
Detailed Description: The study is a Phase 1/2 Study of BLU-451 in Advanced Cancers with Epidermal growth factor receptor (EGFR) Exon 20 Insertion Mutations (Ex20ins). The study has two phases: An initial Phase 1 portion will enroll participants with metastatic cancer with EGFR Ex20ins or other selected EGFR mutations that have progressed after prior systemic therapies and will determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-451. Part 1B dose-escalation will enroll participants with metastatic Non-small Cell Lung Cancer (NSCLC) in the USA only to determine the MTD and/or RP2D of BLU-451 in combination with carboplatin and pemetrexed. A Phase 2 portion will further evaluate the efficacy and safety of BLU-451 as monotherapy at RP2D in participants with NSCLC.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
The University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
New Experimental Therapeutics of Virginia (NEXT Oncology), Fairfax, Virginia, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei City, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital (CGMHLK), Taoyuan, , Taiwan
Contact Details
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