A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVerastem, Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- VS-7375
- cetuximab
Treatment groups
180 Participants
are divided into 3 treatment groupsLocations
14Australia
ICON Cancer CentreQLD 4101, South Brisbane Australia
United States
California
START- Los Angeles90025, Los Angeles United States
Florida
Moffitt Cancer Center33612, Tampa United States
Maryland
Johns Hopkins University21287, Baltimore United States
Sponsors and collaborators
Verastem, Inc.
Lead sponsor
Source ClinicalTrials.gov