Clinical trial · Interventional
Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel Versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients With Metastatic Pancreatic Adenocarcinoma
NCT07491445CI-TRIAL-00124238RASolute 303recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Adenocarcinoma Metastatic | — | UNRESOLVED | — |
| Pancreatic Adenosquamous Carcinoma | Pancreatic Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.85 |
| PDAC | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| daraxonrasib | Drug | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
| nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: daraxonrasib
- description
- study drug
- interventionNames
- Drug: daraxonrasib
- type
- EXPERIMENTAL
- label
- Arm B: daraxonrasib + gemcitabine and nab-paclitaxel
- description
- study drug in combination with chemotherapy
- interventionNames
- Drug: daraxonrasib
- Drug: gemcitabine
- Drug: nab-paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Arm C: gemcitabine and nab-paclitaxel
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * Documented RAS mutation status, either mutant or wild-type. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). * Able to take oral medications. Exclusion Criteria: * Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting. * Active or known history of untreated central nervous system metastatic disease. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 28 days prior to randomization. * Patient is unable or unwilling to comply with protocol-required study visits or procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.