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

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

First listed

Jan 6, 2026

Start date

May 13, 2026

Status verified

Jun 2026

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)

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