A Study YL201 in Patients With Selected Advanced Solid Tumors

Last updated: February 7, 2025
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

YL201 for Injection

Clinical Study ID

NCT06057922
YL201-CN-101-01
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Informed of the trial before the start of the trial and voluntarily sign their nameand 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 contraceptivemeasures from screening to whole study period and within at least 6 months afterlast administration of investigational drug. Male subjects must agree to takehigh-efficiency contraceptive measures from screening to whole study period andwithin 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 studyprotocol.

Exclusion

Exclusion Criteria:

  • Prior treatment with products targeting B7H3 (including antibodies, antibody-drugconjugate [ADC], chimeric antigen receptor T cells [CAR-T], and other drugs).

  • Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1inhibitors.

  • 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 firstadministration of investigational drug.

  • Major surgery (excluding diagnostic surgery) within 4 weeks before firstadministration of investigational drug or likely to require major surgery during thestudy.

  • History of allogenic bone marrow transplantation or solid organ transplantation.

  • Treatment with systemic steroid (Prednisone >10 mg/d or equivalent drugs) or otherimmunosuppressive drugs within 2 weeks before first administration ofinvestigational drug.

  • Live vaccination within 4 weeks before first administration of investigational drugor 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 firstadministration.

  • 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 firstadministration of investigational drug.

  • The toxicity of previous anticancer treatment is not resolved.

  • History of serious hypersensitive reactions to drug substance, inactive compositionsof preparations or other monoclonal antibodies.

  • Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3days before first administration.

  • Any disease, medical state, organ/system dysfunction or social state considered byinvestigators as possibly interfering the subject's capability for ICF signing,producing adverse influence on the subject's capability for cooperation and studyparticipation or influencing the interpretation of study results. Including but notlimited to mental disease or substance/alcohol abuse.

Study Design

Total Participants: 990
Treatment Group(s): 1
Primary Treatment: YL201 for Injection
Phase: 1/2
Study Start date:
September 22, 2023
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • The First Affiliated Hospital of USTC

    Hefei, Anhui
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong
    China

    Active - Recruiting

  • The Frist People's Hospital of Foshan

    Foshan, Guangdong
    China

    Active - Recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong
    China

    Active - Recruiting

  • Yuebei People's Hospital

    Shaoguan, Guangdong
    China

    Active - Recruiting

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi
    China

    Active - Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi
    China

    Site Not Available

  • Liuzhou Worker's Hospital

    Liuzhou, Guangxi
    China

    Active - Recruiting

  • Affiliated Cancer Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan
    China

    Active - Recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Haerbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu
    China

    Active - Recruiting

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu
    China

    Site Not Available

  • Nantong Tumor Hospital

    Nantong, Jiangsu
    China

    Site Not Available

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu
    China

    Active - Recruiting

  • Jiangyin People's Hospital

    Wuxi, Jiangsu
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi
    China

    Active - Recruiting

  • Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning
    China

    Site Not Available

  • The Frist Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong
    China

    Site Not Available

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shandong
    China

    Active - Recruiting

  • Shanxi Cancer Hospital

    Datong, Shanxi
    China

    Site Not Available

  • The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University

    Xian, Shanxi
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Huaxi, Sichuan
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang
    China

    Active - Recruiting

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