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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05546268 | Study of Oral MRT-2359 in Selected Cancer Patients | PHASE1 | ACTIVE NOT_RECRUITING | 174 | — | — | Oct 12, 2022 | Nov 1, 2027 | Mar 3, 2026 | 17 | United States |
| Arm | Type | Description |
|---|---|---|
| Phase 1 Dose Escalation | EXPERIMENTAL | Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL |
| Phase 2 Expansion - NSCLC | EXPERIMENTAL | Patients with NSCLC with high or low L-MYC or N-MYC expression |
| Phase 2 Expansion - SCLC | EXPERIMENTAL | Patients with SCLC |
| Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors | EXPERIMENTAL | Patients with L-MYC or N-MYC amplified solid tumors |
| Phase 2 Expansion - HR-positive, HER2-negative breast cancer | EXPERIMENTAL | Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant |
| Phase 2 Expansion - Prostate Cancer | EXPERIMENTAL | Patients with prostate cancer in combination with enzalutamide |
| Name | Type | Description |
|---|---|---|
| Oral MRT-2359 | DRUG | Orally administered tablets of MRT-2359. |
Phase 1 enrollment population: * NSCLC * SCLC * High-grade neuroendocrine cancer of any primary site * Any solid tumors with L-MYC or N-MYC amplification * DLBCL Phase 2 enrollment population: * Any solid tumors with L-MYC or N-MYC amplification * NSCLC with high or low L-MYC or N-MYC expression ...