Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07126158
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Stereotactic body radiotherapy — RADIATION
    MRIdian and Ethos (adaptive radiation platforms)
  • Defactinib — DRUG
    Taken with 30 minutes of a meal
  • Avutometinib — DRUG
    Can be taken without regard to food.

Study Details

Advanced pancreatic cancer patients receiving treatment of adaptive stereotactic body radiotherapy (SBRT) with concurrent and adjuvant defactinib plus avutometinib will have increased progression-free survival (PFS) compared to historical PFS rates for patients receiving adaptive SBRT alone.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm: SBRT + Defactinib + Avutometinib
    Participants will receive approximately 12 months of treatment on study with 5 fractions of adaptive SBRT with 12 cycles of oral defactinib + avutometinib beginning on Day 2 of radiation. Cycles are 28 days in length. Defactinib is dosed twice a day and avutometinib is dosed twice a week (e.g. Monday and Thursday, Tuesday and Friday, etc.) on a 3 weeks on, 1 week off schedule. The first 6 participants will be enrolled in the Safety Lead-In cohort to monitor for dose-limiting toxicities. Patients who are candidates for surgical resection will undergo standard of care surgery at 2 weeks post-end of SBRT (+/- 1 weeks) or 12 weeks post-end of SBRT (+/- 2 weeks). These patients will discontinue defactinib and avutometinib the day prior to the operation and will resume taking it 4 to 6 weeks after surgery for the remainder of the 12 cycles. Patients who are not candidates for surgical resection will continue to receive defactinib plus avutometinib uninterrupted.
  • Active Comparator: Control Arm: SBRT
    Participants will receive 5 fractions of adaptive SBRT.

Primary Outcome Measure

Progression-free survival (PFS) - Experimental Arm Only [ Time Frame: Through completion of follow-up (up to 2 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Patrick Grierson, M.D., Ph.D.
[email protected]
314-747-7689
Patrick Grierson, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
David DeNardo, Ph.D. (SUB_INVESTIGATOR)
Kian-Huat Lim, M.D., Ph.D. (SUB_INVESTIGATOR)
Julie Schwarz, M.D., Ph.D. (SUB_INVESTIGATOR)
Pamela Samson, M.D. (SUB_INVESTIGATOR)
Carl DeSelm, M.D., Ph.D. (SUB_INVESTIGATOR)
Benjamin Tan, M.D. (SUB_INVESTIGATOR)
Rama Suresh, M.D. (SUB_INVESTIGATOR)
Nikolaos Trikalinos, M.D. (SUB_INVESTIGATOR)
Olivia Aranha, M.D. (SUB_INVESTIGATOR)
Vladimir Khushnir, M.D. (SUB_INVESTIGATOR)
Gabriel Lang, M.D. (SUB_INVESTIGATOR)
Dan Mullady, M.D. (SUB_INVESTIGATOR)
Koushik Das, M.D. (SUB_INVESTIGATOR)
Liang I-Kang, M.D., Ph.D. (SUB_INVESTIGATOR)
Esther Lu, Ph.D. (SUB_INVESTIGATOR)
Natasha Leigh-Matijakovich, M.D. (SUB_INVESTIGATOR)
Roheena Panni, M.D., Ph.D. (SUB_INVESTIGATOR)
Majella Doyle, M.D. (SUB_INVESTIGATOR)
Adeel Khan, M.D. (SUB_INVESTIGATOR)
William Chapman, M.D. (SUB_INVESTIGATOR)
Dominic Sanford, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Washington University School of Medicine· St Louis, MO

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