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NCT Number: NCT06625320

Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site PDAC PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Paoli Calmettes, Marseille, France

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About this study

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.

Patients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 PDAC with metastatic disease.
  • Measurable disease per RECIST 1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation)
  • Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  • Able to take oral medications.

Exclusion criteria

  • Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • History of or known central nervous system metastatic disease.
  • Any conditions that may affect the ability to take or absorb study treatment
  • Major surgery within 4 weeks prior to randomization.
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures

Treatment and study plan

RMC-6236

Drug

Oral Tablets

Gemcitabine

Drug

intravenous (IV) infusion

Nab-paclitaxel

Drug

IV infusion

Irinotecan

Drug

IV infusion

liposomal irinotecan

Drug

IV infusion

5-fluorouracil

Drug

IV infusion

Leucovorin

Drug

IV infusion

Oxaliplatin

Drug

IV infusion

Primary outcomes

  1. Progression free survival (PFS) in the RAS G12-mutant population

    Time frame: Up to approximately 3 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 blinded independent central review (BICR)

  2. Overall survival (OS) in the RAS G12-mutant population

    Time frame: Up to approximately 3 years

    OS is defined as the time from randomization until death from any cause.

Secondary outcomes

  1. PFS in the all-patient population

    Time frame: Up to approximately 3 years

    PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR.

  2. OS in the all-patient population

    Time frame: Up to approximately 3 years

    OS is defined as the time from randomization until death from any cause.

  3. Objective response in the RAS G12 and all-patient populations

    Time frame: Up to approximately 3 years

    Objective response is defined as partial response (PR) or completed response (CR) per RECIST v1.1, assessed by BICR.

  4. Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) in the RAS G12 and all-patient populations

    Time frame: Up to approximately 3 years

    TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale in EORTC QLQ-PAN26.

  5. Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in the RAS G12 and all-patient populations

    Time frame: Up to approximately 3 years

    TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale and global QoL score in EORTC QLQ-C30.

  6. Objective response per investigator in RAS G12 and all- patient populations

    Time frame: Up to approximately 3 years

    Objective response is defined as PR or CR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the investigator.

  7. Duration of response (DOR) in RAS G12 and all-patient populations

    Time frame: Up to approximately 3 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 BICR and by the investigator.

  8. Time to response (TTR) in RAS G12 and all-patient populations

    Time frame: Up to approximately 3 years

    TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by BICR and by the investigator.

  9. Percentage of patients with adverse events (AEs)

    Time frame: Up to approximately 3 years

  10. Pharmacokinetics of RMC-6236 in RAS G12 and all-patient populations

    Time frame: Up to approximately 3 years

    Pharmacokinetics are defined by blood concentrations of RMC-6236 over time.

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study title

RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

Acronym: RASolute 302

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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