Actively Recruiting
RASolute 305: Phase 3, Randomized, Double-blind Study of Chemotherapy With or Without Zoldonrasib for Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
Led by Revolution Medicines, Inc. · Updated on 2026-06-02
670
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an investigational drug called zoldonrasib combined with chemotherapy compared to placebo with chemotherapy for patients with metastatic pancreatic adenocarcinoma that has a specific KRAS G12D mutation. This Phase 3, global, randomized, double-blind study aims to see if adding zoldonrasib improves progression-free survival or overall survival for patients who have not been treated before for this advanced cancer. Participants will be assigned to one of two groups: one group will receive zoldonrasib plus their doctor's choice of chemotherapy, either modified FOLFIRINOX (mFFX) or gemcitabine plus nab-paclitaxel (GnP), while the other group will receive a placebo plus the same chemotherapy options. Zoldonrasib and placebo are given as oral tablets, and chemotherapy drugs like oxaliplatin, leucovorin, 5-fluorouracil, irinotecan, gemcitabine, and nab-paclitaxel are administered by intravenous infusion. The study treatments continue as first-line therapy for metastatic disease. During the study, participants will have regular assessments including scans to measure tumor size, laboratory tests, and questionnaires about quality of life and pain. Safety will be monitored by tracking side effects and changes in vital signs and lab results. The main outcomes measured are progression-free survival and overall survival, with follow-up lasting up to about four years. Researchers will also evaluate treatment response rates and duration, as well as drug concentration in blood during early treatment cycles.
CONDITIONS
Brief Title
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 )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 within 6 weeks prior to screening
- Documented KRAS G12D mutation status
- Measurable disease per RECIST v1.1
- Adequate organ function including bone marrow, liver, kidney, and coagulation
- Able to take oral medications
You will not qualify if you...
- Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting
- Prior systemic RAS-targeted therapy before randomization
- Presence of other known driver mutations with approved targeted therapies
- Active or untreated central nervous system metastatic disease
- Conditions affecting ability to take or absorb study drug
- Major surgery within 28 days before randomization
- Unable or unwilling to comply with required study visits or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants begin taking oral tablets and receive investigator's choice of chemotherapy as part of the study treatment.
Visits occur according to treatment cycles with chemotherapy and oral tablets
Duration - Up to approximately 4 years
Participants are monitored for progression-free survival, overall survival, adverse events, and quality of life after treatment ends.
Regular visits for assessments as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Piedmont Healthcare
Atlanta, Georgia, United States, 30318
Actively Recruiting
Research Team
R
Revolution Medicines Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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