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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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. 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
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/21/2024. Questions regarding updates should be directed to the study team contact

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Carr, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Babiker, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20577628

Mayo Clinic Footer