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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VS-7375 Monotherapy
  • Drug: VS-7375
    Taken by mouth
Experimental
VS-7375 + cetuximab 2L PDAC
  • Drug: VS-7375
    Taken by mouth
  • Drug: cetuximab
    Subcutaneous infusion
Experimental
VS-7375 + cetuximab 1L PDAC
  • Drug: VS-7375
    Taken by mouth
  • Drug: cetuximab
    Subcutaneous infusion

Recruiting Locations

START- Mountain Region
West Valley City, Utah 84119
Contact:
Julianna Daley
Julianna.daley@startresearch.com

More Details

Status
Recruiting
Sponsor
Verastem, Inc.

Study Contact

Verastem Call Center
7812924204
VS-7375-201TrialSupport@verastem.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.