RASolute 305
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)
IRAS ID
1013744
Contact name
Hema Parmar
Contact email
Sponsor organisation
Revolution Medicines Inc.
Eudract number
2025-524928-21
Research summary
Pancreatic cancer is usually caused by changes in a gene called RAS. More than 90% of pancreatic tumours have a fault in this gene. The most common change is called KRAS G12D and is found in about 40% of patients. Despite how common this mutation is, there are currently no approved treatments that specifically target it. As a result, treatment for advanced pancreatic cancer mainly relies on standard chemotherapy, which can extend life but has limited benefit.
This study is testing an investigational medicine called zoldonrasib (RMC-9805). It is designed to block a faulty cancer related protein when the cancer is active. Zoldonrasib has not been approved by the MHRA or any other health authority. The study aims to find out how well zoldonrasib works and how safe it is when combined with chemotherapy. It will compare zoldonrasib plus chemotherapy (modified FOLFIRINOX or gemcitabine with nab paclitaxel) with placebo plus chemotherapy in patients whose pancreatic cancer has the KRAS G12D mutation.
The study is expected to last 4 years. Each participant’s time in the study will depend on how well they tolerate the treatment and how their cancer responds. Participants will be randomly assigned to receive either zoldonrasib or placebo, both given with chemotherapy.
About 670 people will take part worldwide. Screening will take up to four weeks to confirm eligibility. People who are pregnant or breastfeeding cannot take part. Zoldonrasib and placebo are tablets taken once daily. Chemotherapy is given by intravenous infusion during study visits. Participants will attend the study centre two or three times every four weeks, depending on their chemotherapy, until their treatment ends. Follow up will occur about every two months until participation ends for any reason. Disease progression will be assessed by blood test every 4 weeks and by medical imaging (radiology) every 8 weeks until the cancer worsens or the study ends.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
26/SC/0169
Date of REC Opinion
2 Jun 2026
REC opinion
Further Information Favourable Opinion