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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VS-7375 Monotherapy |
|
|
|
Experimental VS-7375 + cetuximab 2L PDAC |
|
|
|
Experimental VS-7375 + cetuximab 1L PDAC |
|
Recruiting Locations
Valkyrie Clinical Trials
Los Angeles, California 90067
Los Angeles, California 90067
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of North Carolina
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
MD Anderson Cancer Center
Houston, Texas 77054
Houston, Texas 77054
START- Mountain Region
West Valley City, Utah 84119
West Valley City, Utah 84119
UVA Health
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Virginia Cancer Specialists
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Verastem, Inc.