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)
Summary
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
Arms & interventions
- DrugVS-7375
Taken by mouth
- Drugcetuximab
Subcutaneous infusion
Outcome measures
Primary
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)
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.
Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations.
Time frame: 6 months
Secondary
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
Study locations (8)
START- Los Angeles
Los Angeles, California, 90025
Moffitt Cancer Center
Tampa, Florida, 33612
START Midwest
Grand Rapids, Michigan, 49546
Washington University
St Louis, Missouri, 63110
START New Jersey
East Brunswick, New Jersey, 08816
START Dallas
Fort Worth, Texas, 76104
START- San Antonio
San Antonio, Texas, 78229
START- Mountain Region
West Valley City, Utah, 84119