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Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week

Defactinib: will be administered at 200 mg orally twice a day (BID).

Avutometinib (VS-6766): will be administered at 3.2 mg orally twice a week Defactinib: will be administered at 200 mg orally twice a day (BID).

Treatment will be for 3 weeks, followed by a 1-week rest period, in each 4-week (28 day) cycle.

Avutometinib (VS-6766) + defactinib

SCC IIT Office

Colleen C McCormick, MD

Ellen Wojcik, MBA-HCM

Christina Washington, MD

The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or cervical cancer.

This is a single-stage exploratory, Phase 2, multicenter, parallel cohort, open label study designed to evaluate efficacy and safety of VS-6766 + defactinib.

Enrolled study patients will receive the study drugs (VS-6766 and defactinib) to take orally based on the study procedures. Patients will follow the study procedures and attend all the study visits where various procedures including physical examinations, vitals, assessing the size of the patient's tumor, and examination of urine and blood may take place. Additional visits may be done to assess any other side effects a patient's experiences.

A single-stage exploratory, Phase 2, multicenter, parallel cohort, open label study designed to evaluate efficacy and safety of VS-6766 + defactinib.

A Phase 2 Study of Avutometinib (VS-6766) Plus Defactinib

A Phase 2 Study of VS-6766 (Dual RAF/MEK Inhibitor) Plus Defactinib (FAK Inhibitor) in Recurrent Gynecological Cancers (DURAFAK)

To evaluate the efficacy of Avutometinib (VS-6766) + defactinib in endometrioid, MOC, HGSOC and cervical cancer patients with RAS/BRAF/NF1 mutations on confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to RECIST 1.1) as assessed by the investigator.

To characterize the safety and toxicity profile of Avutometinib (VS-6766) + defactinib combination measured by the incidence of Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions)

Calculated for those subjects with a CR or PR as elapsed time from the first response to PD or death, as assessed by the investigator.

elapsed time of first treatment to PD or death from any cause.

elapsed time from the first treatment to death.

Spots Global Cancer Trial Database for endometrioid cancer