A Study of VS-6766 v. VS-6766 + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will assess the safety and efficacy of VS-6766 monotherapy and in combination with Defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verastem, Inc.
• Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT); GOG Foundation; Gynecologic Oncology Group

Criteria

Inclusion Criteria:

• Histologically proven LGSOC (ovarian, peritoneal)

• In Part A KRAS mutation, KRAS wt

• Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.

• Measurable disease according to RECIST 1.1

• An Eastern Cooperative Group (ECOG) performance status ≤ 1.

• Adequate organ function

• Adequate recovery from toxicities related to prior treatments

• Agreement to use highly effective method of contraceptive

Exclusion Criteria:

• Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy

• Co-existing high-grade ovarian cancer or another histology

• History of prior malignancy with recurrence <3 years from the time of enrollment

• Major surgery within 4 weeks

• Symptomatic brain metastases requiring steroids or other interventions

• Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy

• For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor

• Active skin disorder that has required systemic therapy within the past year

• History of rhabdomyolysis

• Concurrent ocular disorders

• Concurrent heart disease or severe obstructive pulmonary disease

• Subjects with the inability to swallow oral medications