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NCT06625320 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-06-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Study drug
    intervention Names
    1. Drug: RMC-6236
    label
    RMC-6236
    type
    EXPERIMENTAL
  2. description
    Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX)
    intervention Names
    1. Drug: Gemcitabine
    2. Drug: nab-paclitaxel
    3. Drug: Irinotecan
    4. Drug: Liposomal irinotecan
    5. Drug: 5-fluorouracil
    6. Drug: leucovorin
    7. Drug: Oxaliplatin
    label
    Investigator's choice of standard of care therapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. RMC-6236
    description
    Oral Tablets
    name
    RMC-6236
    type
    DRUG
  2. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    intravenous (IV) infusion
    name
    Gemcitabine
    type
    DRUG
  3. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    nab-paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    Irinotecan
    type
    DRUG
  5. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    Liposomal irinotecan
    type
    DRUG
  6. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    5-fluorouracil
    type
    DRUG
  7. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    leucovorin
    type
    DRUG
  8. arm Group Labels
    1. Investigator's choice of standard of care therapy
    description
    IV infusion
    name
    Oxaliplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
500
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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)
    measure
    Progression free survival (PFS) in the RAS G12-mutant population
    time Frame
    Up to approximately 3 years
  2. description
    OS is defined as the time from randomization until death from any cause.
    measure
    Overall survival (OS) in the RAS G12-mutant population
    time Frame
    Up to approximately 3 years
secondary Outcomes
  1. description
    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.
    measure
    PFS in the all-patient population
    time Frame
    Up to approximately 3 years
  2. description
    OS is defined as the time from randomization until death from any cause.
    measure
    OS in the all-patient population
    time Frame
    Up to approximately 3 years
  3. description
    Objective response is defined as partial response (PR) or completed response (CR) per RECIST v1.1, assessed by BICR.
    measure
    Objective response in the RAS G12 and all-patient populations
    time Frame
    Up to approximately 3 years
  4. description
    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.
    measure
    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
  5. description
    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.
    measure
    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
  6. description
    Objective response is defined as PR or CR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the investigator.
    measure
    Objective response per investigator in RAS G12 and all- patient populations
    time Frame
    Up to approximately 3 years
  7. description
    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.
    measure
    Duration of response (DOR) in RAS G12 and all-patient populations
    time Frame
    Up to approximately 3 years
  8. description
    TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by BICR and by the investigator.
    measure
    Time to response (TTR) in RAS G12 and all-patient populations
    time Frame
    Up to approximately 3 years
  9. measure
    Percentage of patients with adverse events (AEs)
    time Frame
    Up to approximately 3 years
  10. description
    Pharmacokinetics are defined by blood concentrations of RMC-6236 over time.
    measure
    Pharmacokinetics of RMC-6236 in RAS G12 and all-patient populations
    time Frame
    Up to approximately 3 years
Full study description
brief Summary
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.
detailed Description
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).
Source references
references
  1. citation
    O'Reilly EM, Wainberg ZA, Hendifar AE, Borad MJ, Pietrantonio F, Pant S, Hammel P, Cremolini C, Manji GA, Oberstein PE, Garrido-Laguna I, Springfeld C, Azad NS, Ueno M, Chui SY, Zhang Y, Patel H, Lee Y, Salman Z, Wolpin BM; RASolute 302 Trial Investigators. Daraxonrasib or Chemotherapy in Previously Treated Metastatic Pancreatic Cancer. N Engl J Med. 2026 Jul 23;395(4):325-337. doi: 10.1056/NEJMoa2605555. Epub 2026 May 31.
    pmid
    42223072
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        on <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">Drugs@FDA</a>.</p><h2>Efficacy and Safety</h2><p>Efficacy was evaluated in RASolute 302 (NCT06625320), a randomized, open-label, multicenter trial in patients with metastatic pancreatic adenocarcinoma with disease progression after receiving one prior line of
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      source event date
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      source file
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      source title
      FDA approves daraxonrasib for metastatic pancreatic adenocarcinoma

    Preserved source evidence · Not medical advice