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

Part of paid clinical trials in Houston, Texas.

Sponsor: M.D. Anderson Cancer Center
Study ID: NCT07318324
Phase: PHASE1
Status: Not Yet Recruiting

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Conditions

Avutometinib
Endometrial
Phase IB
RAS Pathway

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Avutometinib — DRUG
Given by PO
defactinib — DRUG
Given by PO
Everolimus — DRUG
Given by PO

Study Details

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.

Key Dates

Start date: Jun 3, 2026
Status verified: Dec 2025
Primary completion: Aug 1, 2028
Completion: Aug 1, 2030

Study Design

Enrollment: 31 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Dose Escalation
To be administered per dose level during Days 1-21
Experimental: Dose Expansion
To be administered per identified RP2D during Days 1-2

Primary Outcome Measure

Safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Shannon N Westin, MD
713-794-4314
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
MD Anderson Cancer Center	Houston	Texas	77030	Shannon N Westin, MD [email protected] 713-794-4314 Shannon N Westin, MD (PRINCIPAL_INVESTIGATOR)

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By research site

MD Anderson Cancer Center· Houston, TX