Study on ARV-806 for Adults with Advanced Cancer with KRAS G12D Mutation

Sponsor: Arvinas Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07023731

This clinical trial is testing a new drug, ARV-806, to see if it is safe and can help treat advanced cancers with a specific KRAS mutation. Participants will receive the drug through an IV, and both they and the study team will know they are receiving ARV-806.

Patient Parameters

Parameter	Options

Program Overview

The study aims to evaluate the safety and effectiveness of ARV-806, a new drug for treating advanced cancers with a specific KRAS G12D mutation. The drug works by breaking down a mutated protein in some tumors, potentially slowing or stopping their growth. This is the first time ARV-806 is being tested in humans, and it will be given through an IV. The study has two parts: Part A will test different doses of ARV-806 in small groups, while Part B will use information from Part A to decide on doses for participants with advanced pancreatic cancer with the KRAS mutation.

Eligibility Criteria

Inclusion Criteria

Part A:

Have a confirmed diagnosis of advanced cancer that cannot be surgically removed or has spread.
Have a KRAS G12D mutation in the tumor or blood.
Have tried standard treatments for their cancer type and stage, with no other curative options available, or are unlikely to benefit from standard treatments.
Have at least one tumor that can be measured.

Part B:

Have a confirmed diagnosis of advanced pancreatic cancer with a KRAS G12D mutation.
Be willing to provide a previous tumor sample or undergo a biopsy before treatment.
Have received at least one prior standard treatment for pancreatic cancer.
Have at least one tumor that can be measured.

Part A / Part B:

Be in good overall health with a performance status of 0 or 1.
Have adequate organ function.
Agree to follow pregnancy prevention guidelines.

Exclusion Criteria

Part A / Part B:

Have active cancer spread to the brain.
Have cancer in the membranes covering the brain and spinal cord.
Have uncontrolled high blood pressure despite treatment.
Have previously been treated with drugs targeting KRAS G12D or KRAS G12C mutations.
Cannot comply with the study's prohibited treatments.
Have received systemic cancer treatment or radiation therapy within a specified time before the study.
Have an abnormal heart rhythm or other significant heart issues on an ECG that could affect safety or study results.

Locations

FACILITY	ZIP	CITY	STATE
Clinical Trial Site	49546	Grand Rapids	Michigan
Clinical Trial Site	28078	Huntersville	North Carolina
Clinical Trial Site	78229	San Antonio	Texas
Clinical Trial Site	22031	Fairfax	Virginia

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