Spots Global Cancer Trial Database for (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC
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Trial Identification
Brief Title: (SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC
Official Title: A Phase 1/2 Study Targeting Acquired Resistance Mechanisms in Patients With EGFR Mutant Non-Small Cell Lung Cancer
Study ID: NCT04862780
Conditions
Study Description
Brief Summary: This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-945, a selective EGFR inhibitor, as monotherapy or in combination with osimertinib.
Detailed Description: The study will include an initial Phase 1 portion to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BLU-945 as monotherapy (initially in a QD regimen with the option to evaluate BID dosing, if supported by emerging PK and safety data), as well as an additional dose-escalation portion to determine the RP2D of BLU-945 in combination with osimertinib. The BLU-945 monotherapy Phase 2 expansion groups will consist of patients with tumors harboring specific mutation profiles (EGFR T790M and C797S mutation \[Group 1\]; EGFR T790M but not C797S \[Group 2\]; or EGFR C797S but not T790M \[Group 3\]). The BLU-945 with osimertinib Phase 2 expansion (Group 4) will include approximately 24 evaluable patients, with at least 12 slots reserved for patients with EGFR T790M and C797S mutation.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UC San Diego Moores Cancer Center, La Jolla, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
UC Irvine Health, Chao Family Comprehensive Cancer Center, Orange, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP), Aurora, Colorado, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
NYU Langone Health, Laura and Isaac Perlmutter Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Institut Claudius Regaud (IUCT-O) - Cancer Comprehensive Center, Toulouse, , France
Institut Gustave Roussy - DITEP, Villejuif, , France
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
Seoul National University, Department of Internal Medicine, Seoul, , Korea, Republic of
Yonsei Cancer Center, Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
Asan Medical Center, Department of Oncology, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
The Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, , Netherlands
National Cancer Centre Singapore, Singapore, , Singapore
Vall d'Hebron University Hospital, Oncology Department, Barcelona, , Spain
National Taiwan University Hospital, Taipei, , Taiwan
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Contact Details
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