Study on the Safety and Effects of ALK201 in Adults with Advanced Solid Tumors
Sponsor: Shanghai Allink Biotherapeutics Co., Ltd.
Sponsor score: 0
ClinicalTrials ID:NCT06656390
This clinical trial is testing a new drug, ALK201, to see if it is safe and effective in treating adults with advanced solid tumors. The study will also determine the best dose for future research.
Patient Parameters
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Program Overview
This study is the first to test ALK201 in humans and aims to find out how safe and tolerable it is for adults with advanced solid tumors. Researchers will also study how the body processes the drug and its effects on tumors. The trial will help identify the best dose for future studies.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 to 75 years old.
- Have at least one tumor that can be measured using standard criteria.
- Expected to live at least 3 more months.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have good organ function as determined by medical tests.
- Agree to use effective birth control methods during the study and for 6 months after the last dose if you or your partner can become pregnant. Men should not donate sperm during this time.
Exclusion Criteria
- Have active or past autoimmune diseases that could flare up.
- Have fluid buildup around the lungs, heart, or abdomen that causes symptoms or needs frequent drainage.
- Have allergies to ALK201 or similar drugs.
- Have cancer that started in the brain or active cancer spread to the brain or spinal cord.
- Have severe mouth sores or nosebleeds at the start of the study.
- Have received live vaccines within 4 weeks before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Denver Drug Development Unit | 80218 | Denver | Colorado |
| UCF Lake Nona Cancer Center | 32827 | Orlando | Florida |
| University Medical Center New Orleans | 70112 | New Orleans | Louisiana |
| Sarah Cannon Research Institute Oncology Partners | 37203 | Nashville | Tennessee |
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