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
Treatment
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
Contact
LISA-MARIA YONEMOTO
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06625320
For detailed technical eligibility, visit ClinicalTrials.gov.