Open
Actively Recruiting
Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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. Eligible 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
Join this Trial
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Study Stats
Protocol No.
24-5321
Category
Pancreatic Cancer
Principal Investigator
Contact
Location
- UCLA Westwood