Clinical Trials in Australia / NCT07644559
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
Condition(s) studied
Pancreatic Ductal Adenocarcinoma (PDAC)G12D Mutated KRAS
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Verastem, Inc. trials in Australia
Other trials for the same condition
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