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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
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
Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments.
To evaluate additional efficacy parameters of VS-7375 monotherapy and VS-7375 in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC.
Time frame: 24 months
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax
Maximum concentration (Cmax)
Time frame: 20 weeks
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC
Area under plasma Concentration (AUC) 0 to t
Time frame: 20 weeks
To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type
CA19-9, CEA, CA-125
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)
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START- Los Angeles
Los Angeles, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGValkyrie Clinical Trials
Los Angeles, California, United States
RECRUITINGMayo Clinical Florida
Jacksonville, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITING...and 19 more locations
The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of pancreatic ductal adenocarcinoma patients
Time frame: 24 months
Time to next therapy.
To assess the interval between initiation of study treatment and initiation of subsequent
Time frame: 24 months