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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05786924 | Phase 1/2 Trial of S241656 in Selected RAS/MAPK Mutation- Positive Malignancies | PHASE1 | RECRUITING | 554 | — | — | Apr 18, 2023 | Jun 1, 2028 | Apr 21, 2026 | 11 | United States, Japan |
A DLT is defined as any event meeting the DLT criteria occurring within the first 28-day cycle
| Arm | Type | Description |
|---|---|---|
| Part 1A: Dose Escalation NSCLC | EXPERIMENTAL | S241656 will be administered as a monotherapy at escalating dose levels until the biologically effective dose (BED) range is determined. |
| Part 1B: Dose Escalation GI Tumors | EXPERIMENTAL | S241656 will be administered as a monotherapy at escalating dose levels until the BED range is determined. |
| Part 1C: Dose Escalation PDAC | EXPERIMENTAL | S241656 will be administered in combination with gemcitabine/nab-paclitaxel at escalating dose levels until the BED range is determined. |
| Part 1D: Dose Escalation CRC | EXPERIMENTAL | S241656 will be administered in combination with FOLFOX6/FOLFOX7 or FOLFIRI, and panitumumab or cetuximab at escalating dose levels until the BED range is determined. |
| Part 1E: Dose Escalation Other Solid Tumors | EXPERIMENTAL | S241656 will be administered as a monotherapy at escalating dose levels until the BED range is determined. |
| Part 2A: Dose Optimization NSCLC | EXPERIMENTAL | S241656 will be administered to further characterize the optimal dose. |
| Part 2A1: Dose Expansion NSCLC with KRAS non-G12C mutations | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. |
| Part 2A2: Dose Expansion NSCLC with BRAF mutations | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. |
| Part 2A3: Dose Expansion NSCLC with KRAS non-G12C or BRAF mutations/alterations | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. Participants must also have active CNS metastatic disease |
| Part 2A4: Dose Expansion NSCLC with a KRAS G12C mutation | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. Participants must have received and progressed upon G12C targeted therapy |
| Part 2B1: Dose Expansion PDAC | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. |
| Part 2B2: Dose Expansion CRC | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. |
| Part 2B3: Dose Expansion BTC | EXPERIMENTAL | S241656 will be administered as a monotherapy in the BED range. |
| Part 2C1: Dose Expansion PDAC | EXPERIMENTAL | S241656 will be administered in combination with anti-cancer therapies in the BED range. The combination therapies to be used will be determined in the future. |
| Part 2D1: Dose Expansion CRC | EXPERIMENTAL | S241656 will be administered in combination with anti-cancer therapies in the BED range. The combination therapies to be used will be determined in the future. |
| Part 2F: Exploratory Food Effect | EXPERIMENTAL | S241656 will be administered as a monotherapy. |
| Name | Type | Description |
|---|---|---|
| S241656 | DRUG | RAF inhibitor targeting all classes of oncogenic BRAF alterations (Classes I, II, and III) and constitutively active CRAF, KRAS or NRAS mutations |
| FOLFOX6/FOLFOX7 | DRUG | Used as a combination therapy and administered intravenously |
| FOLFIRI | DRUG | Used as a combination therapy and administered intravenously |
| Cetuximab | DRUG | Used as a combination therapy and administered intravenously |
| Panitumumab | DRUG | Used as a combination therapy and administered intravenously |
| Gemcitabine | DRUG | Used as a combination therapy and administered intravenously |
| Nab-paclitaxel | DRUG | Used as a combination therapy and administered intravenously |
Key Inclusion Criteria: * Life expectancy of ≥ 12 weeks in the opinion of the investigator. * Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations. * Adequate bone marrow and organ function...