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
Recruiting
Trial end date:
2025-12-01
2025-12-01
Target enrollment:
0
0
Participant gender:
Female
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 2Accepts Healthy Volunteers?
NoDetails
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