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Protocol # 22-595

Status

Recruiting

Description

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.

Condition

  • Advanced Solid Tumor

Interventions

  • Mirdametinib
  • BGB-3245

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of treatment emergent adverse events
  • Maximum Tolerated Dose (Part 1 Only)
  • Recommended Phase 2 Dose (Part 1 Only)
  • Objective Response Rate (Part 2 Only)

Secondary Outcome:

  • Objective Response Rate (Part 1 Only)
  • Duration of Response Rate
  • Change in plasma concentrations of mirdametinib and BGB-3245

Enrollment

136

Study Start Date

February 3, 2023

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

SpringWorks Therapeutics, Inc.

Source

SpringWorks Therapeutics, Inc.

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

Clinicaltrials.gov Identifier

NCT05580770

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.