A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid Tumors

Contact:

NCT Number:

Protocol:

AAAV8636

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

The main purpose of this study is to evaluate the safety and effectiveness of the study drug, YL217, in different solid tumor types. We also want to learn: ● The dosage of YL217 that can be safely given to humans ● What effect (good or bad) YL217 has on your cancer ● What happens to YL217 once it is in your body (so called pharmacokinetics; PK) ● What YL217 does to your body MediLink Therapeutics has begun a study of an investigational drug (also known as the “study drug”) called YL217 as a possible treatment for CDH17 expressed solid tumors. CDH17 is a type of protein found on the surface of cells that helps them stick together, and it needs calcium to work properly. In cancer, CDH17 can act as a biomarker—a biological signal that helps doctors detect and monitor disease. The expression level of CDH17—how much of the protein is present in the cells—can give important clues about the cancer’s behavior. Higher or lower levels of CDH17 are often linked to how aggressive the cancer is and can help predict the prognosis, or likely outcome, for the patient. An investigational drug is one that has not been approved by the United States (U.S.) Food and Drug Administration (FDA). This study marks the first time that YL217 has been tested in humans.

Are you Eligible? (Inclusion Criteria)

  • Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF) 2) Able and willing to comply with protocol visits and procedures 3) Aged ≥ 18 years 4. Prior standard treatment have been ineffective or are not available

Specialty Area(s)

Bladder Cancer , Brain and Spinal Tumors, Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Liver Cancer, Lung cancer, Skin cancers, Melanoma, Pancreatic Cancer, Prostate Cancer, Sarcomas (Bone and Soft Tissue), Stomach Cancer, Testicular Cancer, Thyroid Cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032