RecruitingPhase 2interventionalRules rewrite

Phase 2: testing VS-7375 for Pancreatic Ductal Adenocarcinoma (PDAC)

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

Official registry: https://clinicaltrials.gov/study/NCT07644559 · Verastem, Inc. · enrollment listed as 185

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are VS-7375, or cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction). The registry lists allocation as randomized. This study will assess the safety and how well it works of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer

They plan to enroll about 185 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)

Interventions: VS-7375, cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)

Primary outcome (registry wording): Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1

Who it is for (from inclusion criteria)

Ages 18 Years to any
Histologic or cytologic confirmed PDAC
Measurable disease per RECIST 1.1
Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
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) :

Who the registry excludes

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

Public study contact (from the registry)

Verastem Call Center

7812924204

VS-7375-201TrialSupport@verastem.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

38 listed

START- Los Angeles — Los Angeles, California (recruiting)
Cedars-Sinai Medical Center — Los Angeles, California (recruiting)
Valkyrie Clinical Trials — Los Angeles, California (recruiting)
BRCR Global- Coral Springs — Coral Springs, Florida (recruiting)
Mayo Clinical Florida — Jacksonville, Florida (recruiting)
BRCR Global- Tamarac — Tamarac, 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)

+ 11 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07644559 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07644559?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07644559?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary