Spots Global Cancer Trial Database for First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
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Trial Identification
Brief Title: First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Official Title: First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study ID: NCT05768139
Study Description
Brief Summary: Study STX-478-101 is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 in participants with advanced solid tumors with certain mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors and breast cancer; Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California, San Francisco, San Francisco, California, United States
University of Colorado Anschutz Medical Center, Aurora, Colorado, United States
Yale University, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Stefanie Spielman Comprehensive Breast Cancer, Columbus, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
NEXT Virginia, Fairfax, Virginia, United States
Institut Bergonie City: Bordeaux, Bordeau, , France
Institut Gustave Roussy, Villejuif, , France
Fondazione Policlinico Universitario A Gemelli-Rome, Roma, Lazio, Italy
NEXT Oncology - Hospital Quironsalud Madrid, Pozuelo De Alarcón, Madrid, Spain
START Barcelona_HM Nou Delfos, Barcelona, , Spain
Instituto de Investigacion Oncologica Vall d'Hebron, Barcelona, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
START Madrid_Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
START Madrid_Hospital Universitario HM Sanchinarro, Madrid, , Spain
Contact Details
Name: Mark Chao, MD, PhD
Affiliation: Scorpion Therapeutics, Inc.
Role: STUDY_DIRECTOR
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