NCT05580770

Mirdametinib + BGB-3245 in Advanced Solid Tumors

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: SpringWorks Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Mirdametinib	Mirdametinib administered orally
DRUG	BGB-3245	BGB-3245 administered orally

Timeline

• Start date: 2023-02-03
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2022-10-14
• Last updated: 2025-02-17

Locations

8 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study