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

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

  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • G12D Mutated KRAS

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