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 )
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 )
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.
Pancreatic
Phase III
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
5-FU (Fluorouracil),
Gemcitabine,
Irinotecan,
Leucovorin,
Nab-Paclitaxel,
Oxaliplatin,
zoldonrasib
Cardin, Dana
International
Vanderbilt University
09-29-2026
Eligibility
18 Years and older
ALL
false
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.
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.
