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 )
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zoldonrasib, Placebo, Oxaliplatin, Leucovorin (Calcium Folinate).
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RASolute 305: 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
Overview
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.
Detailed description
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with Investigator choice of chemotherapy will improve progression-free survival or overall survival compared to placebo in combination with Investigator choice of chemotherapy when given to patients with previously untreated, 1L metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Choice of chemotherapy (mFFX or GnP) will be at the discretion of the Investigator.
Patients will be randomized to one of two arms: zoldonrasib + Investigator choice of chemotherapy (Arm A) or placebo + Investigator choice of chemotherapy (Arm B).
Interventions
- Drug Zoldonrasib
oral tablets - Drug Placebo
oral tablets - Drug Oxaliplatin
IV infusion - Drug Leucovorin (Calcium Folinate)
IV infusion - Drug 5-Fluorouracil
IV infusion - Drug Irinotecan
IV infusion - Drug Gemcitabine (GEM)
IV infusion - Drug Nab-paclitaxel
IV infusion
Primary outcome measures
- Progression free survival (PFS) [Time frame: Up to approximately 4 years]
- Overall survival (OS) [Time frame: Up to approximately 4 years]
Secondary outcome measures (9)
- PFS per blinded independent central review (BICR) [Time frame: Up to approximately 4 years]
- Objective response rate (ORR) [Time frame: Up to approximately 4 years]
- Duration of response (DOR) [Time frame: Up to approximately 4 years]
- Incidence of adverse events (AEs) [Time frame: Up to approximately 4 years]
- Changes in vital signs [Time frame: Up to approximately 4 years]
- Changes in clinical laboratory test values [Time frame: Up to approximately 4 years]
- Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) pain scale [Time frame: Up to approximately 4 years]
- Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status score [Time frame: Up to approximately 4 years]
- Concentration of zoldonrasib in Arm A [Time frame: Up to Cycle 5 Day 1 (each cycle is 28 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- The University of Arizona Cancer Center-North Campus — Tucson
- Moffitt Cancer Center — Tampa
- Piedmont Healthcare — Atlanta
- University of Chicago Medical Center — Chicago
- Johns Hopkins University — Baltimore
Identifiers
NCT: NCT07621718 · RMC-9805-305