Overview

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