Mirdametinib + BGB-3245 in Advanced Solid Tumors

Part of paid clinical trials in La Jolla, California.

Sponsor
SpringWorks Therapeutics, Inc.
Study ID
NCT05580770
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirdametinib 2mg — DRUG
    Mirdametinib 2mg administered orally
  • BGB-3245 5mg — DRUG
    BGB-3245 5mg administered orally
  • Mirdametinib 3mg — DRUG
    Mirdametinib 3mg administered orally
  • Mirdametinib 4mg — DRUG
    Mirdametinib 4mg administered orally
  • BGB-3245 10mg — DRUG
    BGB-3245 10mg administered orally
  • BGB-3245 20mg — DRUG
    BGB-3245 20mg administered orally

Study Details

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.

Key Dates

First listed
Oct 14, 2022
Start date
Feb 3, 2023
Status verified
May 2026
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation, Cohort 1
    Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
  • Experimental: Phase 1 Dose Escalation, Cohort 2
    Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
  • Experimental: Phase 1 Dose Escalation, Cohort 3
    Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
  • Experimental: Phase 1 Dose Escalation, Cohort 4
    Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
  • Experimental: Phase 1 Dose Escalation, Cohort 5
    Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events [ Time Frame: All adverse events were collected from the time of signing ICF until 30 days after the last dose of study treatment (an average of 3.48 months and up to 16.76 months). ]

Locations (6)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
Yale-New Haven Hospital-Yale Cancer CenterNew HavenConnecticut06520-
Massachusetts General HospitalBostonMassachusetts02114-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CAYale-New Haven Hospital-Yale Cancer Center· New Haven, CTMassachusetts General Hospital· Boston, MAUniversity Hospitals Cleveland Medical Center· Cleveland, OHHospital of the University of Pennsylvania· Philadelphia, PATexas Oncology-Baylor Charles A. Sammons Cancer Center· Dallas, TX

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