Neoadjuvant Avutometinib/Defactinib and mFOLFIRINOX Combination Therapy in Pancreatic Adenocarcinoma

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor: University of Virginia
Study ID: NCT07824960
Phase: PHASE1/PHASE2
Status: Not Yet Recruiting

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Conditions

Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Carcinoma
PDAC - Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Avutometinib (VS-6766) + Defactinib (VS-6063) — DRUG
Participants will receive avutometinib and defactinib in combination with mFOLFIRINOX (standard of care chemotherapy) in 28-day cycles for up to 6 cycles.

Study Details

The goal of this study is to find out if taking two oral study drugs (avutometinib and defactinib) are safe for patients with pancreatic ductal adenocarcinoma (PDAC). Researchers also want to see if the drugs can slow down tumor growth and shrink tumors for possible surgery. These drugs are approved by the FDA to treat a certain kind of ovarian cancer. This study has two parts: * Part A is for patients whose cancer has spread to other parts of the body. * Part B is for patients whose cancer has not spread, but who cannot have surgery. Participants will take both drugs as told by their doctor with their regular cancer medicine. Participants will also give blood samples throughout the study. These samples will help researchers learn about how participants respond to treatment and about their pancreatic cancer.

Key Dates

First listed: Sep 17, 2026
Start date: Oct 1, 2026
Status verified: Sep 2026
Primary completion: Apr 30, 2029
Completion: Apr 30, 2030

Study Design

Enrollment: 31 participants (estimated)
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Arms

Experimental: Neoadjuvant avutometinib + defactinib with standard of care chemotherapy
Avutometinib and defactinib will be taken for 3 weeks, followed by a 1-week rest period in each 4 week cycle.