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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07621718 | Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 ) | PHASE3 | RECRUITING | 670 | — | — | May 22, 2026 | Apr 22, 2030 | Jun 2, 2026 | 1 | United States |
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by Investigator.
OS is defined as the time from randomization until death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: zoldonrasib + chemotherapy | EXPERIMENTAL | study drug in combination with Investigator choice chemotherapy (mFFX or GnP) |
| Arm B: placebo + chemotherapy | PLACEBO_COMPARATOR | placebo in combination with Investigator choice chemotherapy (mFFX or GnP) |
| Name | Type | Description |
|---|---|---|
| Zoldonrasib | DRUG | oral tablets |
| Placebo | DRUG | oral tablets |
| Oxaliplatin | DRUG | IV infusion |
| Leucovorin (Calcium Folinate) | DRUG | IV infusion |
| 5-Fluorouracil | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Gemcitabine (GEM) | DRUG | 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 screening. * Documente...