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Mirdametinib + BGB-3245 in Advanced Solid Tumors
Sponsor: SpringWorks Therapeutics, Inc.
Summary
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.
Official title: A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
23
Start Date
2023-02-03
Completion Date
2025-01-15
Last Updated
2026-05-01
Healthy Volunteers
No
Conditions
Interventions
Mirdametinib 2mg
Mirdametinib 2mg administered orally
BGB-3245 5mg
BGB-3245 5mg administered orally
Mirdametinib 3mg
Mirdametinib 3mg administered orally
Mirdametinib 4mg
Mirdametinib 4mg administered orally
BGB-3245 10mg
BGB-3245 10mg administered orally
BGB-3245 20mg
BGB-3245 20mg administered orally
Locations (8)
UC San Diego Moores Cancer Center
La Jolla, California, United States
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Calvary Mater Newcastle
Waratah, Australia