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OncoMatch/Clinical Trials/NCT05512208

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

Is NCT05512208 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Avutometinib (VS-6766) + defactinib for endometrioid cancer.

Phase 2RecruitingUniversity of OklahomaNCT05512208Data as of Jun 2026

Treatment: Avutometinib (VS-6766) + defactinibThe 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 solid gynecological cancer.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Avutometinib (VS-6766) + defactinib

Cancer type

Ovarian Cancer

Cervical Cancer

Tumor Agnostic

Biomarker criteria

Required: KRAS mutation

mutated RAS

Required: NRAS mutation

mutated RAS

Required: HRAS mutation

mutated RAS

Required: BRAF type I mutation

BRAF (type I, II, and/or III)

Required: BRAF type II mutation

BRAF (type I, II, and/or III)

Required: BRAF type III mutation

BRAF (type I, II, and/or III)

Required: NF1 loss of function

NF-1 loss of function

Required: KRAS activation

RAS activation

Required: NRAS activation

RAS activation

Required: HRAS activation

RAS activation

Disease stage

Required: Stage FIGO STAGE II-IV (FIGO)

Metastatic disease required

metastatic disease (FIGO stage II-IV)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 99
Female only

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy — metastatic

Cannot have received: mek inhibitor

Cannot have received: raf inhibitor

Lab requirements

Blood counts

hemoglobin ≥9.0 g/dL; platelets ≥100,000/mm3; ANC ≥1500/mm3

Kidney function

creatinine clearance rate of ≥50 mL/min (Cockcroft-Gault) or serum creatinine ≤ 1.5 x ULN

Liver function

total bilirubin ≤1.5 × ULN (subjects with Gilbert syndrome may enroll if total bilirubin is <3.0 mg/dL); ALT and AST ≤2.5 × ULN (or <5x ULN in subjects with liver metastases)

Cardiac function

left ventricular ejection fraction ≥ 55% by ECHO or MUGA scan; baseline QTc interval < 460 ms (average of triplicate readings) (CTCAE Grade1) using Fredericia's QT correction formula

Must have adequate organ function defined by the following laboratory parameters: ... see protocol for full details

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • AdventHealth · Orlando, Florida
  • Louisiana State University Medical Center New Orleans · New Orleans, Louisiana
  • University of New Mexico Comprehensive Cancer Center · Albuquerque, New Mexico
  • Stephenson Cancer Center · Oklahoma City, Oklahoma

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See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05512208 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior mek inhibitor, raf inhibitor disqualifies patients from enrollment.

Does this trial require KRAS?

Yes, KRAS mutation is a required biomarker for enrollment.

Does this trial require NRAS?

Yes, NRAS mutation is a required biomarker for enrollment.

Does this trial require HRAS?

Yes, HRAS mutation is a required biomarker for enrollment.

What disease stage is eligible?

Stage FIGO STAGE II-IV is required (metastatic disease required).

Is there an age limit?

Yes. Patients must be 99 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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