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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07491445 | Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma | PHASE3 | RECRUITING | 900 | — | — | Mar 9, 2026 | Mar 1, 2029 | Jun 3, 2026 | 5 | United States |
| NCT07252232 | Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) | PHASE3 | RECRUITING | 500 | — | — | Dec 15, 2025 | Jul 10, 2030 | Jun 4, 2026 | 17 | United States, Puerto Rico +1 |
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
OS is defined as the time from randomization until death from any cause.
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
| Arm | Type | Description |
|---|---|---|
| Arm A: daraxonrasib | EXPERIMENTAL | study drug |
| Arm B: daraxonrasib + gemcitabine and nab-paclitaxel | EXPERIMENTAL | study drug in combination with chemotherapy |
| Arm C: gemcitabine and nab-paclitaxel | ACTIVE_COMPARATOR | SOC chemotherapy |
| daraxonrasib | EXPERIMENTAL | study drug |
| SOC Observation | NO_INTERVENTION | Patients randomized to the comparator control arm will receive SOC observation. |
| Name | Type | Description |
|---|---|---|
| daraxonrasib | DRUG | oral tablets |
| gemcitabine | DRUG | intravenous (IV) infusion |
| nab-paclitaxel | DRUG | IV infusion |
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed pancreatic adenocarcinoma. * Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. * Do...