Clinical Trial 21119

• Overview

  Study Title:

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

  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)

  Objective:

  Primary Objectives (Parts A and B) Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, for subsequent evaluation for efficacy in the expansion phase (Part B). Part B: To determine the efficacy of the optimal regimen identified from Part A. Secondary Objectives (Parts A and B) To characterize the safety and toxicity profile of VS-6766 as a monotherapy and in combination with defactinib in LGSOC. Part A: To evaluate additional efficacy parameters for VS-6766 monotherapy and in combination with defactinib. Part B: To evaluate additional efficacy parameters for the optimal regimen identified in Part A. To characterize the pharmacokinetics (PK) of VS-6766, defactinib, and relevant metabolites.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Defactinib (VS-6063); VS-6766 ()

• Inclusion Criteria

  • Histologically proven LGSOC (ovarian, peritoneal)
  • Tumor with known KRAS mutational status using a validated testing method (blood or tissue) prior to treatment assignment. Adequate material as defined in the lab manual must be available for central confirmation prior to treatment assignment.
  • 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 > Adequate organ function
  • Adequate recovery from toxicities related to prior treatments
  • Female patients with reproductive potential agree to use highly effective method of contraceptive (per Clinical Trial Facilitation Group [CFTG] recommendations during trial and for 1 month following the last dose of study intervention.
  • Other criteria may apply

• Exclusion Criteria

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study intervention
  • Co-existing high-grade ovarian cancer or another histology
  • History of prior malignancy with recurrence > Patients who are deemed in the opinion of the treating physician to be appropriate candidates for a debulking surgery. These patients should preferentially receive surgery prior to consideration of trial therapy.
  • Major surgery within 4 weeks
  • Treatment with warfarin. Patients on warfarin for deep vein thrombosis/pulmonary embolism can be converted to low-molecular-weight heparin or direct oral anticoagulants (DOACs)
  • Exposure to medications (with or without prescription) supplements, herbal remedies, or foods with potential for drug-drug interactions with study intervention and during the course of therapy.
  • Symptomatic brain metastases requiring steroids or other interventions
  • Known severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection (clinical symptoms) > For patients 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

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