Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer
NCT ID: NCT05669482
Last Updated: 2025-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2023-03-22
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
To determine the recommended phase 2 dose (RP2D) for gemcitabine Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib in patients with untreated metastatic PDAC.
avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
The RP2D of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel determined in Part A will be used in Part B dose expansion.
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
To determine the efficacy of the RP2D identified in Part A in untreated metastatic PDAC patients
avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
The RP2D of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel determined in Part A will be used in Part B dose expansion.
Interventions
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avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
The RP2D of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel determined in Part A will be used in Part B dose expansion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Verastem, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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MD Verastem
Role: STUDY_DIRECTOR
Verastem, Inc.
Locations
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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
Countries
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Other Identifiers
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VS-6766-205
Identifier Type: -
Identifier Source: org_study_id
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