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Recruiting NCT07644559

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

Phase II Interventional Pancreatic Ductal Adenocarcinoma (PDAC) G12D Mutated KRAS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VS-7375, cetuximab.
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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

Interventions

  • Drug VS-7375
    Taken by mouth
  • Drug cetuximab
    Subcutaneous infusion

Primary outcome measures

  • Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 [Time frame: 6 months]
  • 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. [Time frame: 6 months]
Secondary outcome measures (6)
  • Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments. [Time frame: 24 months]
  • Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax [Time frame: 20 weeks]
  • Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC [Time frame: 20 weeks]
  • To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type [Time frame: Up to 2.5 years]
  • To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30) [Time frame: 24 months]
  • Time to next therapy. [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Histopathology 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 other documented co-existing common RAS mutation(s)
  • 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 or H2 blocker within 5 days
  • Inability to swallow oral medication
  • Other protocol-defined inclusion/exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 21 centers
  • START- Los Angeles — Los Angeles
  • Cedars-Sinai Medical Center — Los Angeles
  • Valkyrie Clinical Trials — Los Angeles
  • Moffitt Cancer Center — Tampa
  • Johns Hopkins University — Baltimore
  • Dana-Farber Cancer Institute — Boston
  • University of Michigan — Ann Arbor
  • START Midwest — Grand Rapids
  • … and 13 more centers
Australia · 2 centers
  • ICON Kurralta Park — Kurralta Park
  • ICON Cancer Centre — South Brisbane

Identifiers

NCT: NCT07644559 · VS-7375-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗