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Mirdametinib + BGB-3245 in Advanced Solid Tumors

NCT05580770 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-05-01

Study results available
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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

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

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2025-01-15
Completion
2025-01-15
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05580770 on ClinicalTrials.gov