RASolute 303
Research type
Research Study
Full title
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
IRAS ID
1013716
Contact name
William Novotny
Contact email
Sponsor organisation
Revolution Medicines Inc.
Eudract number
2025-525088-34
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test the effectiveness of treatment with an experimental drug called daraxonrasib (RMC-6236) in participants with metastatic pancreatic adenocarcinoma, as first-line treatment.
The study will evaluate how whether daraxonrasib given either on it’s own (monotherapy) or in combination with chemotherapy treatment (gemcitabine and nab-paclitaxel), will improve progression free survival and/or overall survival compared with standard of care gemcitabine and nab-paclitaxel.
Daraxonrasib has not been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) or any other health authorities in any countries.
The drug is currently also being investigated in studies in patients with metastatic pancreatic cancer (cancer that has already spread outside of the pancreas).
The entire study is expected to last about 3 years. A participant’s time in the study will depend on when they joined and whether their cancer progresses. If the cancer progresses, participants will continue to be contacted for information about health and survival every 3 months.
-If participants agree to join this study they will be randomised in a 1:1:1 ratio to receive:
- Daraxonrasib monotherapy (once daily)
- Daraxonrasib (once daily) + gemcitabine and nab-paclitaxel (days 1 and 15 of a 28-day cycle) for a maximum of 6 cycles, followed by daraxonrasib monotherapy
- Gemcitabine and nab-paclitaxel (days 1, 8 and 15 of a 28-day cycle).
Approximately 900 participants will take part in this study globally. Tumour assessments will be performed every 8 weeks until disease progression.
This study is funded by Revolution Medicines, Inc.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
26/NE/0074
Date of REC Opinion
11 Jun 2026
REC opinion
Further Information Favourable Opinion