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Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma (RASolute 309)

1 september 2026 uppdaterad av: Revolution Medicines, Inc.

A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients With Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma

The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib plus zoldonrasib will improve progression-free survival and/or overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic KRAS G12D-mutated pancreatic adenocarcinoma.

Patients will be randomized to one of two arms: daraxonrasib + zoldonrasib (Arm A) or gemcitabine and nab-paclitaxel (Arm B).

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Revolution Medicines Study Director
  • Telefonnummer: 1-844-2-REVMED
  • E-post: medinfo@revmed.com

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.
  • No prior treatment in the locally advanced unresectable or metastatic setting
  • Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
  • Documented KRAS G12D mutation status.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).

Exclusion Criteria:

  • Mutation status with known driver mutations for which there are approved targeted therapies.
  • Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.
  • Tumors determined to originate from non-pancreatic primary sites.
  • Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.
  • Active or known history of untreated central nervous system metastatic or leptomeningeal 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.
  • Additional inclusion & exclusion criteria may apply.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm A: daraxonrasib + zoldonrasib
combination of study drugs
Läkemedel: daraxonrasib
muntlig tabletter
Läkemedel: zoldonrasib
oral tablets
Experimentell: Arm B: gemcitabine and nab-paclitaxel
chemotherapy
Läkemedel: nab-paklitaxel
IV infusion
Läkemedel: gemcitabin
intravenös (IV) infusion

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival (OS)
Tidsram: Up to approximately 4 years
OS is defined as the time from randomization until death from any cause.
Up to approximately 4 years
Progression free survival (PFS)
Tidsram: Up to approximately 4 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
Up to approximately 4 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of adverse events (AEs)
Tidsram: Up to approximately 4 years
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Up to approximately 4 years
Changes in clinical laboratory test values
Tidsram: Up to approximately 4 years
Number of patients with changes from baseline in clinical laboratory test values
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
Tidsram: Up to approximately 4 years
EORTC QLQ-PAN26 consists of 26 questions relating to disease symptoms, treatment side effects and emotional issues specific to pancreatic cancer. The pancreatic pain subscale assesses abdominal pain, back pain, and pain while lying down. Change in score from baseline in the pain subscale will be assessed with higher scores on the pain subscale indicating more severe pain and worsening function.
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
Tidsram: Up to approximately 4 years
EORTC QLQ-C30 consists of 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties), and an overall scale for global health status. It uses a mix of 4-point scales and 7-point scales. Change from baseline in EORTC QLQ-C30 global health status will be assessed. Higher scores on functional scales reflect better functioning, whereas higher scores on symptom scales reflect higher symptom burden.
Up to approximately 4 years
PFS by blinded independent central review (BICR)
Tidsram: Up to approximately 4 years
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per RECIST v1.1 by BICR
Up to approximately 4 years
Objective response rate (ORR)
Tidsram: Up to approximately 4 years
Objective response is defined as partial response (PR) or complete response (CR) per RECIST v1.1, as assessed by the Investigator.
Up to approximately 4 years
Duration of response (DOR)
Tidsram: Up to approximately 4 years
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by the investigator.
Up to approximately 4 years
Changes in vital signs
Tidsram: Up to approximately 4 years
Number of patients with changes from baseline in vital signs
Up to approximately 4 years
Concentration of daraxonrasib and zoldonrasib in Arm A
Tidsram: Up to Cycle 5 Day 1 (each cycle is 28 days)
Pre-dose trough and post-dose blood concentrations of daraxonrasib and zoldonrasib at selected visits.
Up to Cycle 5 Day 1 (each cycle is 28 days)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Revolution Medicines, Inc.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

28 augusti 2026

Primärt slutförande (Beräknad)

1 mars 2029

Avslutad studie (Beräknad)

1 april 2030

Studieregistreringsdatum

Först inskickad

1 september 2026

Först inskickad som uppfyllde QC-kriterierna

1 september 2026

Första postat (Faktisk)

8 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RMC-9805-309

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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