Mirdametinib + BGB-3245 for Advanced Cancer

Recruiting at 13 trial locations

Overseen By SpringWorks Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: SpringWorks Therapeutics, Inc.

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: CNS metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

23 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with advanced solid tumors that haven't improved with at least one prior treatment, or when no other treatments are available. Participants must be over 18, have a performance status of ≤2 (which means they can do some light activity), and have specific genetic changes in their tumor related to the MAPK pathway. They should not have had recent cancer therapy or surgery, and cannot join if they have certain medical conditions like severe heart disease or uncontrolled infections.

Inclusion Criteria

Measurable disease per RECIST 1.1

Able to provide informed consent

My organs are functioning well and I haven't had a transfusion in the last 14 days.

Exclusion Criteria

I have a parathyroid disorder or had cancer-related high calcium levels.

I cannot swallow pills.

I haven't had cancer treatment in the last 2 weeks or 5 half-lives.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of mirdametinib and BGB-3245 to determine the maximum tolerated dose

Up to 18 months

Dose Expansion

Participants receive the recommended phase 2 dose of mirdametinib and BGB-3245 to evaluate efficacy and safety

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Treatment Details

Interventions

• BGB-3245
• Mirdametinib

Trial Overview The trial is testing a combination of two drugs: Mirdametinib and BGB-3245. It's an early-phase study where doses are increased gradually to find safe levels before expanding to more patients. The goal is to see how well these drugs work together against different types of solid tumors with mutations affecting cell growth pathways.

Participant Groups

Group I: Phase 2 Dose Expansion C Experimental Treatment 2 Interventions

Participants with NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutation or BRAF Fusion mutation

Group II: Phase 2 Dose Expansion B Experimental Treatment 2 Interventions

Participants with NSCLC harboring KRAS mutations

Group III: Phase 2 Dose Expansion A Experimental Treatment 2 Interventions

Participants with cutaneous melanoma harboring NRAS mutations

Group IV: Phase 1 Dose Escalation Cohorts Ranging in Dose Experimental Treatment 2 Interventions

Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway

Who Is Running the Clinical Trial?

SpringWorks Therapeutics, Inc.

Lead Sponsor

Trials

14

Recruited

900+