A Study YL201 in Patients With Selected Advanced Solid Tumors
NCT ID: NCT06057922
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
990 participants
INTERVENTIONAL
2023-09-22
2028-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 dose expansion stage
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.
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.
Phase 2 stage with expanded sample size
Patients will be treated with YL201 intravenous (IV) infusion at PR2D 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old and ≤75 years old
* Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC/HNSCC/Sarcoma/PDAC/HCC/BTC
* At least one extracranial measurable lesion according to RECIST 1.1.
* Archived or fresh tumor tissue samples can be provided.
* Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1.
* Female subjects with fertility must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. Male subjects must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug.
* Life expectancy ≥3 months.
* Capable or willing to observe the visits and procedures stipulated in study protocol.
Exclusion Criteria
* Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1 inhibitors.
* Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study.
* Washout period of previous anticancer treatment was insufficient before first administration of investigational drug.
* Major surgery (excluding diagnostic surgery) within 4 weeks before first administration of investigational drug or likely to require major surgery during the study.
* History of allogenic bone marrow transplantation or solid organ transplantation.
* Treatment with systemic steroid (Prednisone \>10 mg/d or equivalent drugs) or other immunosuppressive drugs within 2 weeks before first administration of investigational drug.
* Live vaccination within 4 weeks before first administration of investigational drug or likely to require live vaccine inoculation during the study.
* Evidence of leptomeningeal metastasis or carcinomatous meningitis.
* Evidence of brain metastasis or spinal cord compression.
* Evidence of cardiovascular disease with uncontrolled state or clinical significance.
* Clinically significant concomitant lung disease.
* Diagnosed as Gilbert syndrome.
* Complicated with uncontrolled third-space effusion .
* History of gastrointestinal perforation and/or fistula within 6 months before first administration.
* History of serious infection (Grade ≥3 of NCI CTCAE) before first administration.
* Known as infection with human immunodeficiency virus (HIV).
* Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
* History of any other primary malignant tumor within 5 years before first administration of investigational drug.
* The toxicity of previous anticancer treatment is not resolved.
* History of serious hypersensitive reactions to drug substance, inactive compositions of preparations or other monoclonal antibodies.
* Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3 days before first administration.
* Any disease, medical state, organ/system dysfunction or social state considered by investigators as possibly interfering the subject's capability for ICF signing, producing adverse influence on the subject's capability for cooperation and study participation or influencing the interpretation of study results. Including but not limited to mental disease or substance/alcohol abuse.
18 Years
75 Years
ALL
No
Sponsors
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MediLink Therapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anhui Provincial Cancer Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of USTC
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The Frist People's Hospital of Foshan
Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Jiangyin People's Hospital
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
The Frist Hospital of China Medical University
Shenyang, Liaoning, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Shanxi Cancer Hospital
Datong, Shanxi, China
The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
Xian, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Huaxi, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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Ma Y, Yang Y, Huang Y, Fang W, Xue J, Meng X, Fan Y, Fu S, Wu L, Zheng Y, Liu J, Liu Z, Zhuang W, Rosen S, Qu S, Li B, Li M, Zhao Y, Yang S, Ji Y, Sommerhalder D, Luo S, Yang K, Li J, Lv D, Zhang P, Zhao Y, Hong S, Zhang Y, Zhao S, Chin S, Zhang X, Lian W, Cai J, Xue T, Zhang L, Zhao H. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. Nat Med. 2025 Jun;31(6):1949-1957. doi: 10.1038/s41591-025-03600-2. Epub 2025 Mar 13.
Other Identifiers
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YL201-CN-101-01
Identifier Type: -
Identifier Source: org_study_id
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