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A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
Sponsor: Arvinas Inc.
Summary
This is a study to evaluate the safety and potential anti-tumor activity of an investigational agent called ARV-806 in Adults with Advanced Cancer having a specific KRAS mutation. This is an open-label study which means that participants and study staff will know that all participants will receive ARV-806. Researchers think that ARV-806 can work by breaking down a specific protein with a mutation that is present in some tumors, which might help prevent or slow tumors from growing. This will be the first time ARV-806 will be used in people. The investigational drug will be given through a vein. This is called intravenous (IV) infusion. This study will include 2 parts. In Part A (Phase 1), different small groups of participants will receive lower to higher doses of ARV-806. Adults with advanced cancers having a specific KRAS mutation will be included. In Part B (Phase 2), participants will be assigned to receive one of up to 2 dose levels decided by the information from Part A. Part B will include participants with advanced pancreatic ductal cancer having a specific KRAS mutation.
Official title: A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ARV-806 in Participants With KRAS G12D Mutated Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
159
Start Date
2025-05-29
Completion Date
2029-04-02
Last Updated
2026-02-19
Healthy Volunteers
No
Conditions
Interventions
ARV-806
Intravenous infusion at assigned dose and dosing schedule
Locations (14)
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
New Haven, Connecticut, United States
Clinical Trial Site
Tampa, Florida, United States
Clinical Trial Site
Indianapolis, Indiana, United States
Clinical Trial Site
Grand Rapids, Michigan, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
New York, New York, United States
Clinical Trial Site
Huntersville, North Carolina, United States
Clinical Trial Site
Cleveland, Ohio, United States
Clinical Trial Site
Houston, Texas, United States
Clinical Trial Site
San Antonio, Texas, United States
Clinical Trial Site
Salt Lake City, Utah, United States
Clinical Trial Site
Fairfax, Virginia, United States