A Multi-center, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors
MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 1\) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF). 2\) Age ≥18 years. 3) Be willing to follow and be able to complete all the study procedures. 4) Body mass index (BMI) within the range of 18 to 32 kg/m2, and body weight ≥45kg for female subjects. 5） Patients with histologically or cytologically confirmed locally advanced or metastatic ovarian cancer (OC), non-squamous non-small cell lung cancer (NSQ NSCLC), renal cell carcinoma (RCC), endometrial canc…
Interventions
- Drugintravenous (IV) infusion
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
Locations (43)
- Sarah Cannon Research Institute (SCRI)- DenverDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Florida Cancer Specialists - Lake MaryLake Mary, Florida
- Norton Cancer InstituteLouisville, Kentucky
- Washington University School of Medicine - Center for advanced MedicineSt Louis, Missouri
- Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas Vegas, Nevada