Study Details

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A Study of YL201 in Patients With Advanced Solid Tumors

This is a study of an investigational drug called YL201 as a possible treatment for advanced solid tumors. YL201 is thought to work by interrupting DNA replication in cancer cells, via focused delivery of the cytotoxic agent to the cancer cell. YL201 has shown some anti-cancer effects against cancer cells in the laboratory and in experimental animals. The main purpose of this study is to learn how safe the study drug and how well the study drug works.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

In this study you will receive an IV infusion of the investigational study drug YL201 on day one of four 21-day treatment cycles. You will have blood, urine and tumor samples taken for analysis. If you have benefited from receiving YL201 during the first four cycles, you will continue to receive study drug YL201 in 21-day treatment cycles until you have an unacceptable side effect to the study drug or your cancer gets worse, or you decide not to keep on study treatment for any reason. The tissue samples will be taken to assess the potential biological activity of YL201 in the tumor tissue. A series of blood samples will be taken to better understand what your body does to YL201 and the effects of YL201 in your body. Throughout the study you will be asked how you feel and will be encouraged to report to your study doctor if you feel unwell at any time. You will have tumor assessment and imaging tests using x-rays (CT-scan), magnetic fields (MRI scan), or radioactive substances (PET-scan) performed to determine the status and spread of your cancer.

Incentives

Investigational study drug YL201

In-person visits:
22-30

Phone or online visits:
4+

Total length of participation:
6 months from screening to end of safety follow-up. Survival follow-up will continue every 3 months until death or lost to follow-up.

Looking for Specific Volunteers

Able to participate:

You have a confirmed diagnosis of an advanced solid lung or esophageal tumor
You have a life expectancy of greater or equal of 3 months
You have already received a platinum-containing chemotherapy and have relapsed or progressed while on the treatment or within 6 months of the last dose
You have at least 1 evaluable tumor lesion according to RECIST version 1.1.

Not eligible if:

You have had multiple primary malignancies within 3 years
You have had prior treatment with an agent targeting B7H3 (including antibody, ADC, chimeric antigen receptor T cell [CAR-T], and other drugs)
You have had prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor
Your cancer spread to the your central nervous system and you experience spinal cord compression or take corticosteroids or anticonvulsants as a result
You have uncontrolled or clinically significant cardiovascular disease.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Manning Hall (UNC-Chapel Hill, School of Information and Library Science)
216 Lenoir Dr, Chapel Hill, NC 27599, USA

Additional Study Information

Principal Investigator

Shetal Patel
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck, Lung)

IRB Number

24-3022

ClinicalTrials.gov

NCT05434234