Study on ACR-2316 for Treating Specific Advanced Solid Tumors
Sponsor: Acrivon Therapeutics
ClinicalTrials ID:NCT06667141
This clinical trial is testing a new drug, ACR-2316, to see if it is safe and effective for treating certain advanced solid tumors that have spread or returned after treatment.
Patient Parameters
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Program Overview
This study is the first to test ACR-2316 in humans. It aims to find out if the drug is safe and how well it works in treating specific advanced solid tumors that have either spread or come back after treatment. Researchers will also determine the best dose for future studies and examine how the drug behaves in the body.
Description
The trial is divided into two phases, Phase 1 and Phase 2. In Phase 1, researchers will focus on the safety and tolerability of ACR-2316, as well as its initial effectiveness against tumors. They will also identify the highest dose that patients can tolerate and recommend a dose for Phase 2. Additionally, the study will look at how the drug is processed in the body and its genetic effects. Participants will receive ACR-2316 as a single treatment to evaluate its impact on their cancer.
Eligibility Criteria
Inclusion Criteria
- Must agree to participate and sign a consent form.
- Have a confirmed diagnosis of specific advanced solid tumors that have spread, returned, or are locally advanced.
- Willing to provide medical reports and genetic test results.
- Have received no more than three different treatments for cancer that has returned.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least three months.
- Have at least one tumor that can be measured using standard criteria.
- Have good organ function based on medical tests.
- Cancer must have progressed after previous treatment.
Exclusion Criteria
- Have known brain tumors that are causing symptoms.
- Have received systemic cancer treatment within three weeks before starting the study drug.
- Have had radiation therapy aimed at curing the cancer within four weeks before starting the study drug.
- Have had radiation therapy to relieve symptoms within two weeks before starting the study drug.
- Women who are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| HonorHealth Research Institute | 85016 | Phoenix | Arizona |
| Precision NextGen Oncology & Research Center | 90212 | Beverly Hills | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| Denver Health One | 80218 | Denver | Colorado |
| Florida Cancer Specialist | 34232 | Sarasota | Florida |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| University of Michigan | 48109 | Ann Arbor | Michigan |
| Roswell Park Comprehensive Cancer Center | 14203 | Buffalo | New York |
| Montefiore Medical Centre | 10461 | The Bronx | New York |
| Carolina BioOncology Institute | 28078 | Huntersville | North Carolina |
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