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.
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Clinical Trial Information
Trial Contact: Grofsik, Kiera; Djuro, Victor; Walton, Sherri; Donaldson, Karin M
Trial Phone: 321.841.6626 ; 321.841.7477 ; 321.841.1907 ; 321.841.9821
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IRB No: W22.247.11
Protocol Abbrev: MEKRAF-AST-101
Principal Investigator: Wasif M. Saif, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: MEKRAF-AST-101
Treatment: Drug: Mirdametinib Mirdametinib administered orally (Other Name: PD-0325901) Drug: BGB-3245 BGB-3245 administered orally
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05580770
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Objective
Primary Objectives:
Part 1 and Part 2: To Evaluate the Safety and Tolerability of Mirdametinib and BGB-3245 Administered as a Combination in the Eligible Participant Population.
Part 1 only: To Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) for Mirdametinib and BGB-3245 Administered as a Combination in the Eligible Participant Population.
Part 2 only: To Determine the Preliminary Anti-Tumor Efficacy for the RP2D of Mirdametinib and BGB-3245 Administered as a Combination in the Eligible Participant Population. -
Key Eligibility
Inclusion Criteria:
• Able to provide informed consent
• At least 18 years of age on day of signing ICF
• Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
• Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
• Part 2: oncogenic mutation or genomic aberration defined below:
o Cohort A: cutaneous melanoma harboring NRAS mutations.
o Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation.
o Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation.
• Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
• Measurable disease per RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Adequate organ function and no transfusion within 14 days of first dose
