To confirm the efficacy of Avutometinib in combination with Defactinib in Japanese patients with LGSOC.

A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2021240021

Enrollment

Registered

2024-08-23

Start date

2024-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Recurrent Low-Grade Serous Ovarian Cancer, LGSOC, Dual RAF/MEK Inhibitor, FAK Inhibitor

Interventions

Patients will receive avutometinib 3.2 mg PO twice weekly (BIW) for 21 days in each 28-day cycle and defactinib 200 mg PO twice daily (BID) for 21 days in each 28-day cycle. Study treatment should co

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: The main Inclusion Criteria are as follows. Please contact us for more details. 1.Histologically proven LGSOC (ovarian, fallopian, peritoneal) (LGSOC in conjunction with serous borderline tumor is permitted) (Adequate tumor tissue must be available for central confirmation of LGSOC. ) 2. Documented mutational status of KRAS by a validated diagnostic test from tumor tissue. Adequate tumor tissue (preferably less than 5 years as defined in the laboratory manual) must be available for submission. 3. Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy regimen. 4. At least one measurable lesion according to RECIST v1.1. 5. Adequate organ function.

Exclusion criteria

Exclusion criteria: The main Exclusion Criteria are as follows. Please contact us for more details. 1. Systemic anti-cancer therapy within 4 weeks of the first dose of study intervention or clinical trial. 2. High-grade ovarian cancer or mixed histology. 3. History of prior malignancy with recurrence within the last 3 years. 4. Specific concurrent ocular disorders: (exanple) History of glaucoma, History of retinal pathology, Corneal disorders etc. 5. Uncontrolled (persistent) hypertension: systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.

Design outcomes

Primary

Measure	Time frame
Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) as assessed by the blinded independent central radiology review committee (BICR)	—

Secondary

Measure	Time frame
The main secondary endpoints are as follows Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions)	—

Contacts

Public ContactTina Kitano

Japan Clinical Research Operations K.K.

tina.kitano@jcro.jp+81-3-6205-4165

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026