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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Verastem, Inc.
• Treatments: Gemcitabine; Paclitaxel

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