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TERMINATED
NCT05580770
PHASE1/PHASE2

Mirdametinib + BGB-3245 in Advanced Solid Tumors

Sponsor: SpringWorks Therapeutics, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

Mirdametinib 2mg

Mirdametinib 2mg administered orally

DRUG

BGB-3245 5mg

BGB-3245 5mg administered orally

DRUG

Mirdametinib 3mg

Mirdametinib 3mg administered orally

DRUG

Mirdametinib 4mg

Mirdametinib 4mg administered orally

DRUG

BGB-3245 10mg

BGB-3245 10mg administered orally

DRUG

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