A Study YL201 in Patients With Selected Advanced Solid Tumors

A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: YL201 for Injection

• Study Type: Interventional
• Enrollment (Estimated): 990
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • Anhui Provincial Cancer Hospital
    • Hefei, Anhui, China
      • The First Affiliated hospital of USTC
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Foshan, Guangdong, China
      • The Frist People's Hospital of Foshan
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
    • Guangzhou, Guangdong, China
      • Affiliated Cancer Hospital and institute of Guangzhou Medical University
    • Jiangmen, Guangdong, China
      • Jiangmen Central Hospital
    • Shaoguan, Guangdong, China
      • Yuebei People's Hospital
    • Zhuhai, Guangdong, China
      • The Fifth Affiliated Hospital Sun Yat-Sen University
  • Guangxi
    • Guilin, Guangxi, China
      • The Second Affiliated Hospital of Guilin Medical University
    • Liuchow, Guangxi, China
      • Liuzhou Worker's Hospital
    • Liuchow, Guangxi, China
      • Liuzhou people's Hospital
    • Nanning, Guangxi, China
      • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi, China
      • Affiliated Cancer Hospital of Guangxi Medical University
  • Hainan
    • Haikou, Hainan, China
      • The First Affiliated Hospital of Hainan Medical University
  • Hebei
    • Chengde, Hebei, China
      • Affiliated Hospital of Chengde Medical University
  • Heilongjiang
    • Haerbin, Heilongjiang, China
      • Harbin Medical University Cancer Hospital
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science and Technology
    • Xinxiang, Henan, China
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
    • Changsha, Hunan, China
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • The First People's Hospital of Changzhou
    • Nantong, Jiangsu, China
      • Nantong Tumor Hospital
    • Wuxi, Jiangsu, China
      • Affiliated Hospital of Jiangnan University
    • Wuxi, Jiangsu, China
      • Jiangyin People's Hospital
    • Xuzhou, Jiangsu, China
      • Xuzhou Central Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • First Affiliated Hospital of Gannan Medical University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
    • Jinan, Shandong, China
      • Shandong Cancer Hospital and Institute
    • Linyi, Shandong, China
      • Linyi Cancer Hospital
  • Shanxi
    • Datong, Shanxi, China
      • Shanxi Cancer hospital
    • Xian, Shanxi, China
      • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Cancer Hospital
    • Huaxi, Sichuan, China
      • West China Hospital of Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Taizhou, Zhejiang, China
      • Taizhou Hospital of Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
• 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 products targeting B7H3 (including antibodies, antibody-drug conjugate [ADC], chimeric antigen receptor T cells [CAR-T], and other drugs).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).	Time Frame: Approximately within 36 months
Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer	PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline	Time Frame: Approximately within 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the PK parameter AUC		Approximately within 36 months
Characterize the PK parameter Cmax		Approximately within 36 months
Characterize the PK parameter Ctrough		Approximately within 36 months
Characterize the PK parameter CL		Approximately within 36 months
Characterize the PK parameter Vd		Approximately within 36 months
Characterize the PK parameter t1/2		Approximately within 36 months
Assess the incidence of anti-YL201 antibodies		Approximately within 36 months
Evaluate the disease control rate (DCR) for patients assessed using RECIST version 1.1	Approximately within 36 months	DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Evaluate the duration of response (DoR) for patients assessed using RECIST version 1.1	Approximately within 36 months	DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only.
Evaluate the time to response (TTR) for patients assessed using RECIST version 1.1	TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).	Approximately within 36 months
Evaluate the progression-free survival (PFS) for patients assessed using RECIST version 1.1	PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.	Approximately within 36 months
Evaluate the overall survival (OS) for patients	OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.	Approximately within 36 months
Evaluate the radiographic progression-free survival (rPFS) for patients with prostate cancer		Approximately within 36 months
Evaluate the time to PSA progression (TTPP) for patients with prostate cancer	Defined as the time from the first investigational drug administration to the first recording of PSA progression.	Approximately within 36 months
Evaluate the PSA duration of response (PDoR) for patients with prostate cancer	Defined as the time from PSA reduction of ≥50% compared with baseline to PSA progression.	Approximately within 36 months
Evaluate the best PSA response for patients with prostate cancer	Defined as the maximum percentage of PSA changes at any time during the study.	Approximately within 36 months

Collaborators and Investigators

• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: September 21, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Antibody-drug conjugate
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: YL201-CN-101-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No