NCT07318324

Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To find the recommended dose of the combination of avutometinib, defactinib, and everolimus in patients with endometrial cancer that is recurrent and has abnormal RAS activity. The safety and effects of this combination will also be studied.

Detailed description

Primary Objectives To identify the recommended phase 2 dosing (RP2D) of the combination of avutometinib, defactinib and everolimus in participants with recurrent, RAS pathway mutant endometrial cancer. Secondary Objectives To evaluate the tolerability of the RP2D of avutometinib, defactinib and everolimus including dose limiting toxicities that occur during cycle 1.

Conditions

• Phase IB
• Avutometinib
• RAS Pathway
• Endometrial

Interventions

Type	Name	Description
DRUG	Avutometinib	Given by PO
DRUG	defactinib	Given by PO
DRUG	Everolimus	Given by PO

Timeline

• Start date: 2026-06-03
• Primary completion: 2028-08-01
• Completion: 2030-08-01
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study