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Active, not recruiting Phase 1/2

A Study YL201 in Patients With Selected Advanced Solid Tumors

NCT06057922 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2023-09-22
Last updated
2026-03-12

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

YL201 for Injection →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

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)

FacilityCityRegionStatus
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.

Official registry record

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