Study on ARV-6723 Alone and With Pembrolizumab for Advanced Solid Tumors
Sponsor: Arvinas Inc.
ClinicalTrials ID:NCT07749586
This clinical trial is testing a new drug, ARV-6723, to see if it is safe and can help fight cancer in adults with advanced solid tumors. The study will explore how ARV-6723 works on its own and when combined with another drug, pembrolizumab.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and potential effectiveness of a new drug called ARV-6723 in treating advanced solid tumors. Participants will receive ARV-6723 as an oral tablet, either by itself or combined with pembrolizumab, which is given through an IV or injection. This is an open-label study, meaning both participants and researchers will know the treatment being given. The study will be conducted in multiple parts, starting with small groups receiving different doses of ARV-6723 to find the best dose for further testing.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced solid tumor that cannot be surgically removed or has spread.
- Have previously tried at least one treatment targeting specific immune pathways, such as PD-1, PD-L1, or CTLA-4.
- Have received standard treatment for their cancer type and stage, but have no other effective treatment options left, or are not expected to benefit from standard treatment, or have chosen not to undergo standard treatment.
- Show evidence of cancer progression on scans and have at least one measurable tumor that has not been treated with radiation or has grown since radiation.
- Be in good overall health with an ECOG performance status of 0 or 1, or possibly 2 after discussion with the study team.
- Have adequate organ function.
Exclusion Criteria
- Have active brain cancer that is growing or causing symptoms.
- Have cancer in the lining of the brain and spinal cord (carcinomatous meningitis).
- Have known allergies to ARV-6723, pembrolizumab, or their ingredients.
- Have active autoimmune diseases or a history of autoimmune diseases that could flare up.
- Have had severe immune-related side effects from previous treatments targeting PD-1, CTLA-4, or LAG-3.
- Have previously used any drugs targeting HPK1.
- Have received cancer treatment or radiation within 14 days before starting the study.
- Are currently using medications or supplements that cannot be stopped before and during the study.
- Have an abnormal ECG that could affect safety or study results.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Clinical Trial Site | 28078 | Huntersville | North Carolina |
| Clinical Trial Site | 78229 | San Antonio | Texas |
| Clinical Trial Site | 22031 | Fairfax | Virginia |
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