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Recruiting Phase 2

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer

NCT07644559 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2026-06-16
Last updated
2026-10-09

Condition(s) studied

Pancreatic Ductal Adenocarcinoma (PDAC)G12D Mutated KRAS

Investigational drug(s) / intervention(s)

VS-7375 →cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction) →

VS-7375: Taken by mouth

cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction): Subcutaneous infusion

Study summary

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologic or cytologic confirmed PDAC * Measurable disease per RECIST 1.1 * Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) * ECOG PS=0 or 1 Adequate organ function VS-7375 + cetuximab (2L PDAC) : -Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months VS-7375 + cetuximab (1L PDAC) : -Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease Exclusion criteria: * Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS * Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter * Major surgery within 4 weeks of first treatment dose * Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose * History of drug-induced Interstitial Lung Disease * Receipt of prior direct RAS inhibitor * Untreated or symptomatic CNS metastasis * Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter * Receipt of PPI, P-CABs, or H2 blocker within 5 days * Inability to swallow oral medication * Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

  • Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 — 6 months
    Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)
  • To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC. — 6 months
    Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations.

Trial sites (31)

FacilityCityRegionStatus
START- Los Angeles Los Angeles California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Mayo Clinical Florida Jacksonville Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
University of Chicago Chicago Illinois Recruiting
Johns Hopkins University Baltimore Maryland Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
START Midwest Grand Rapids Michigan Recruiting
Mayo Clinical Rochester Rochester Minnesota Recruiting
Washington University St Louis Missouri Recruiting
START New Jersey East Brunswick New Jersey Recruiting
NYU-Manhattan New York New York Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
START Dallas Fort Worth Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
START- San Antonio San Antonio Texas Recruiting
START- Mountain Region West Valley City Utah Recruiting
UVA Health Charlottesville Virginia Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Virginia Mason Seattle Washington Recruiting
UW Health Madison Wisconsin Recruiting
Macquarie University Hospital Sydney New South Wales Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
ICON Kurralta Park Kurralta Park South Australia Recruiting
ICON Cancer Centre South Brisbane Australia Recruiting
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting
Princess Margaret Cancer Center Toronto Ontario Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07644559 on ClinicalTrials.gov ↗ ← All trials in Australia