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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: KRAS Activating Mutation, Metastatic Cancer, Pancreas Cancer, Neoplasms Pancreatic, Malignant Neoplasm of Pancreas

In brief

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.

Key facts

Study ID

NCT05669482

Run by

Verastem, Inc.

People needed

40

Starts

2023-03-22

Expected to finish

2027-08-31

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• University of Chicago — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
• New York Presbyterian/Weill-Cornell Medical Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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