First-in-Human Study of ADCE-D01 for Soft Tissue Sarcoma
Sponsor: Adcendo ApS
ClinicalTrials ID:NCT06797999
This clinical trial is testing a new drug, ADCE-D01, to see if it is safe and effective for treating soft tissue sarcoma, a type of cancer that affects the body's connective tissues.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment called ADCE-D01 for patients with soft tissue sarcoma, a cancer that has spread or cannot be removed by surgery. Researchers will monitor how well patients tolerate the treatment and whether it helps reduce the cancer.
Description
This study is focused on understanding how safe and tolerable the new drug ADCE-D01 is for patients with soft tissue sarcoma. Researchers will look at any side effects that occur and how severe they are. They will also assess how well the drug works by measuring the reduction in tumor size, how long the response lasts, and the time it takes for the cancer to progress. The study will use standard criteria to evaluate these outcomes.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of soft tissue sarcoma that has spread or cannot be surgically removed.
- Have received one or two previous treatments for the cancer that did not work.
- Have at least one tumor that can be measured by scans.
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have a life expectancy of at least 3 months.
- Male participants must agree to use condoms during treatment and for 4 months after, and not donate sperm during this time.
- Female participants must not be pregnant or breastfeeding and must agree to use effective contraception during treatment and for 7 months after.
Exclusion Criteria
- Have received any cancer treatment or experimental drug within 4 weeks before starting the study.
- Have cancer that started in the brain or has spread to the brain and is untreated.
- Have significant heart disease.
- Have an active HIV infection.
- Have active liver disease due to hepatitis B.
- Have a history of certain lung diseases or current lung inflammation as shown on a CT scan.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Denver | 80208 | Aurora | Colorado |
| University of Miami - Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Memorial Sloan Kettering Cancer Center | 10065 | New York City | New York |
| University Of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.