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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 )

NCT07621718 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Pancreatic Cancer
  • Pancreatic Cancer Metastatic
  • PDAC
  • PDAC - Pancreatic Ductal Adenocarcinoma
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Adenocarcinoma
  • Pancreatic Adenosquamous Carcinoma

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

Sponsors & Collaborators

  • Revolution Medicines, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-22
Primary Completion
2028-12-30
Completion
2030-04-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621718 on ClinicalTrials.gov