Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03905148 | Study of the Safety and Pharmacokinetics of BGB-283 (Lifirafenib) and PD-0325901 (Mirdametinib) in Participants With Advanced or Refractory Solid Tumors | PHASE1 | COMPLETED | 91 | — | — | May 1, 2019 | Oct 23, 2025 | Jan 7, 2026 | 6 | United States, Australia |
Incidence and severity of AEs and SAEs and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
| Arm | Type | Description |
|---|---|---|
| Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens. | EXPERIMENTAL | Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day |
| Part B: Expansion | EXPERIMENTAL | Approximately 20 participants with NRAS mutated solid tumors will be enrolled |
| Name | Type | Description |
|---|---|---|
| Lifirafenib | DRUG | RAF Dimer Inhibitor |
| mirdametinib | DRUG | MEK Inhibitor |
Key Inclusion Criteria: 1. Able to provide informed consent 2. Age 18 on day of signing informed consent form (ICF) or of the legal age of consent in the jurisdiction in which the study is taking place 3. Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or c...