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โ† Trials
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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

RecruitingPhase 3Ages 18 Years - anyAllRevolution Medicines, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 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.
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What it tests

  • daraxonrasib
  • gemcitabine
  • nab-paclitaxel
  • zoldonrasib
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Where

5 sites
Mayo Clinic Arizona
Phoenix, United States
HonorHealth Research Institute
Scottsdale, United States
Mayo Clinic Florida
Jacksonville, United States
Moffitt Cancer Center
Tampa, United States
Mayo Clinic Rochester
Rochester, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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