RecruitingPhase 1Phase 2NCT07023731

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

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


Sponsor

Arvinas Inc.

Enrollment

159 participants

Start Date

May 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called ARV-806 in adults with advanced cancer that has a specific gene mutation called KRAS G12D, which is commonly found in pancreatic cancer and other solid tumors. **You may be eligible if...** - You are an adult with an advanced cancer that cannot be removed with surgery or has spread - Your tumor has been confirmed to have the KRAS G12D mutation (by a blood or tissue test) - You have already received standard treatments and have no other curative options - You have at least one measurable tumor on imaging - For pancreatic cancer specifically: you have received at least one prior systemic therapy **You may NOT be eligible if...** - You have not tried available standard treatments - You are unable to provide tumor tissue or undergo a biopsy - You have certain serious heart conditions or other major health concerns that would make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGARV-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07023731


Related Trials