A Study YL201 in Patients With Selected Advanced Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
YL201 for Injection: Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle; and at dose levels of 1.0 mg/kg and 1.2 mg/kg administered on Days 1 and 8 of each Q3W treatment cycle.
Study summary
This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2).
Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), head and neck squamous cell carcinoma (HNSCC), sarcoma, ductal adenocarcinoma of pancreas (PDAC), hepatocellular carcinoma (HCC), biliary tract cancer (BTC), etc..
Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.
Eligibility
Primary outcome measure(s)
- Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment — By the global end of trial date, approximately within 36 months
- Evaluate the objective response rate (ORR) for patients with solid tumors which assessed using RECIST version 1.1 — Time Frame: Approximately within 36 months
ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). - Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer — Time Frame: Approximately within 36 months
PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| Anhui Provincial Cancer Hospital | Hefei | Anhui | |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | |
| The First Affiliated Hospital of USTC | Hefei | Anhui | |
| The Second Hospital of Anhui Medical University | Hefei | Anhui | |
| Peking University People's Hospital | Beijing | Beijing Municipality | |
| Chongqing University Cancer Hospital | Chongqing | Chongqing Municipality | |
| Fujian Cancer Hospital | Fuzhou | Fujian | |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| Dongguan People's Hospital | Dongguan | Guangdong | |
| The Frist People's Hospital of Foshan | Foshan | Guangdong | |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | |
| Affiliated Cancer Hospital and Institute of Guangzhou Medical University | Guangzhou | Guangdong | |
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | |
| Jiangmen Central Hospital | Jiangmen | Guangdong | |
| Yuebei People's Hospital | Shaoguan | Guangdong | |
| The Fifth Affiliated Hospital Sun Yat-Sen University | Zhuhai | Guangdong | |
| The Second Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | |
| Liuzhou People's Hospital | Liuzhou | Guangxi | |
| Liuzhou Worker's Hospital | Liuzhou | Guangxi | |
| Affiliated Cancer Hospital of Guangxi Medical University | Nanning | Guangxi | |
| The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | |
| The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | |
| Affiliated Hospital of Chengde Medical University | Chengde | Hebei | |
| Harbin Medical University Cancer Hospital | Haerbin | Heilongjiang | |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | |
| The First People's Hospital of Changzhou | Changzhou | Jiangsu | |
| Nantong Tumor Hospital | Nantong | Jiangsu | |
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | |
| Jiangyin People's Hospital | Wuxi | Jiangsu | |
| Xuzhou Central Hospital | Xuzhou | Jiangsu | |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi | |
| Jiangxi Cancer Hospital (Jiangxi Second People's Hospital) | Nanchang | Jiangxi | |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | |
| The First Hospital of Jilin University | Changchun | Jilin |
+ 12 more sites — see the full list on the official registry below.
More MediLink Therapeutics (Suzhou) Co., Ltd. trials in China
Other trials for the same condition
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 NCT06057922 on ClinicalTrials.gov ↗ ← All trials in China