A Clinical Study of YL205 in Patients With Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
intravenous (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
Study 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
Primary outcome measure(s)
- To evalue the DLTs — Approximately within 36 months
- To evalue the TEAEs — Approximately within 36 months
Treatment Emergent Adverse Event - To evalue the TRAEs — Approximately within 36 months
Treatment Related Adverse Event - To evalue the serious adverse events (SAEs) — Approximately within 36 months
- Determination of the MTD of YL205 in the pivotal clinical study — Approximately within 36 months
- Determination of the RED of YL205 in the pivotal clinical study — Approximately within 36 months
- Determination of the RP2D of YL205 in the pivotal clinical study — Approximately within 36 months
- Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1 — Approximately within 36 months
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarah Cannon Research Institute (SCRI)- Denver | Denver | Colorado | Recruiting |
| Yale Cancer Center | New Haven | Connecticut | Recruiting |
| Florida Cancer Specialists - Lake Mary | Lake Mary | Florida | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Recruiting |
| Washington University School of Medicine - Center for advanced Medicine | St Louis | Missouri | Recruiting |
| Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley | Las Vegas | Nevada | Recruiting |
| Southwest Women's Oncology | Albuquerque | New Mexico | Recruiting |
| Stephenson Cancer Center (Oklahoma) | Oklahoma City | Oklahoma | Recruiting |
| Providence Cancer Institute - Franz Clinic | Portland | Oregon | Recruiting |
| Sarah Cannon Research (SCRI)-Tennessee | Nashville | Texas | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| Fujian Provincial Cancer Hospital | Fuzhou | Fujian | Recruiting |
| Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University | Guangzhou | Guangdong | Recruiting |
| Guangxi Medical University Cancer Hospital | Nanning | Guangxi | Recruiting |
| Hainan General Hospital | Haikou | Hainan | Recruiting |
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | Recruiting |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | Recruiting |
| Anyang Cancer Hospital | Anyang | Henan | Recruiting |
| Henan Cancer Hospital | Zhengzhou | Henan | Recruiting |
| Jingzhou First People's Hospital | Jingzhou | Hubei | Recruiting |
| Hubei Cancer Hospital | Wuhan | Hubei | Recruiting |
| Tongji Medical College of Hust TongJi Hospital | Wuhan | Hubei | Recruiting |
| Union hospital Tongji Medical Colllege Huazhong University of School and Technology | Wuhan | Hubei | Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | Recruiting |
| Hunan Provincial Cancer Hospital | Changsha | Hunan | Recruiting |
| Xiangya Hospital of Central South University | Changsha | Hunan | Recruiting |
| Jilin Provincial Cancer Hospital | Changchun | Jilin | Recruiting |
| Liaoning Cancer Hospital | Shenyang | Liaoning | Recruiting |
| The People's Hospital of Liaoning Province | Shenyang | Liaoning | Recruiting |
| Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | Recruiting |
| Qilu Hospital of Shandong University | Jinan | Shandong | Recruiting |
| Shandong Cancer Hospital | Jinan | Shandong | Recruiting |
| Linyi Cancer Hospital | Linyi | Shandong | Recruiting |
| Shanxi Cancer Hospital | Taiyuan | Shanxi | Recruiting |
| The First Affiliated Hospital of XI'AN Jiaotong University | Xi’an | Shanxi | Recruiting |
| West China Second University Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
| Yunnan Cancer Hospital | Kunming | Yunnan | Recruiting |
| The First Affiliated Hospital. Zhejiang University School of Medicine | Hangzhou | Zhejiang | Recruiting |
| Peking Union Medical College Hospital | Beijing | China | Recruiting |
| Chinese People's Liberation Army Army Characterstic Medical Center | Chongqing | China | Recruiting |
+ 3 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06459973 on ClinicalTrials.gov ↗ ← All trials in the USA