Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

Sponsor: Verastem, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05669482

Patient View

This Phase 1/2 study evaluates the safety and efficacy of avutometinib (VS-6766) and defactinib with gemcitabine and nab-paclitaxel in untreated metastatic PDAC patients. Eligible participants are adults with ECOG ≤ 1 and adequate organ function. Exclusions include prior PDAC treatment and certain health conditions. The RP2D from Part A will guide Part B dosing.

Patient Parameters

Program Overview

This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.

Description

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients previously untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects ≥ 18 years of age
  • Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma.
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1
  • Measurable disease according to RECIST 1.1
  • Adequate organ function
  • Adequate cardiac function
  • Agreement to use highly effective method of contraceptive

Exclusion Criteria

  • Patients with pancreatic neuroendocrine tumors
  • Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma
  • Prior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAK
  • History of prior malignancy, with the exception of curatively treated malignancies
  • Major surgery within 4 weeks (excluding placement of vascular access)
  • Concurrent heart disease or severe obstructive pulmonary disease
  • Concurrent ocular disorders
  • Active skin disorder that has required systemic therapy within the past 1 year
  • Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome
  • Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy

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