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RECRUITING
NCT07023731
PHASE1/PHASE2

A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation

Sponsor: Arvinas Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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