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 )
Recruiting · NCT07621718 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
5-FluorouracilGemcitabine (GEM)IrinotecanLeucovorin (Calcium Folinate)Nab-paclitaxelOxaliplatinPlaceboZoldonrasib
What this trial is about
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- Documented KRAS G12D mutation status.
- 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 unresectable locally advanced or metastatic setting.
- Prior systemic RAS-targeted therapy any time prior to randomization.
- Presence of other known driver mutations with approved targeted therapies
- 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.
Where it is running
6 locations listed across 6 US states.
- The University of Arizona Cancer Center-North Campus - Tucson, Arizona, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Astera Cancer Care - East Brunswick, New Jersey, United States