Clinical trials›NSCLC›Injection›Trial details
OpenMedium-term (3–5 yrs)Treatment Study

A Study of YL202 in Selected Patients With Advanced Solid Tumors

For Condition: NSCLCFor Condition: Breast CancerFor Condition: HNSCCFor Condition: Locally Advanced or Metastatic Solid Tumors

ID: NCT06107686

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Injections / IV Shots
Expected Availability Horizon
Medium-term (3–5 yrs away)
StageMiddle Clinical Stage: Designed to check if the treatment actively works for the condition in moderate groups (100–300 people). Gathers early success indicators.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.

Read Full Scientific Objectives & Methods

This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.

Study Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
200 patients (Estimated)
Study Start Date
2023-12-15
Est. Primary Completion
2026-11
Tested Drugs & Treatment Groups
DRUGYL202 should be intravenously infused

For each patient, YL202 should be intravenously infused over 60±10 min.

Treatment Arms Description

EXPERIMENTALCorhort A

YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic NSCLC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

EXPERIMENTALCorhort B

YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic BC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

EXPERIMENTALCorhort C

YL202 is provided as the lyophilized powder, 200 mg/vial. Locally advanced or metastatic HNSCC patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

EXPERIMENTALCorhort D

YL202 is provided as the lyophilized powder, 200 mg/vial. Other locally advanced cancer patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 18 Years and 75 Years
Full Criteria Checklist
Who Can Join
  • Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF).
  • Subjects aged from 18-75 (inclusive) years.
  • Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc..
  • At least one extracranial measurable lesion according to RECIST 1.1.
  • Archived or fresh tumor tissue samples can be provided.
  • With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  • The function of organs and bone marrow meets the requirements within 7 days before the first dose.
  • Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product.
  • With expected survival ≥ 3 months.
  • Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.
Who Cannot Join
  • With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates \[ADCs\]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
  • Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
  • Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study.
  • The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
  • Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study.
  • Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
  • Prior treatment with systemic steroids (prednisone \> 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product.
  • Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period.
  • With meningeal metastasis or cancerous meningitis.
  • With brain metastasis or spinal cord compression.
  • Patients with uncontrolled or clinically significant cardiovascular diseases.
  • Clinically significant complicated pulmonary disorders.
  • Patients diagnosed with Gilbert syndrome.
  • Those with uncontrolled effusion in the third space requiring repeated drainage.
  • With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator.
  • With serious infection before the first dose.
  • With known human immunodeficiency virus (HIV) infection.
  • With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
  • Unrelieved toxicity of previous anti-tumor therapy.
  • With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
  • Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
  • With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator.
What is this Study Measuring?

Primary Outcome Measures

  • ORR assessed according to RECIST v1.1 — Time Frame: By the end of trial date, 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).

  • Determination of the recommended dose of YL202 in the pivotal clinical study — Time Frame: By the end of trial date, approximately within 36 months
View Secondary Outcome Measures (17)
  • Progression-free survival (PFS) assessed according to RECIST v1.1 — Time Frame: approximately within 36 months
  • Clinical benefit rate (CBR) assessed according to RECIST v1.1 — Time Frame: approximately within 36 months
  • depth of response (DpR) assessed according to RECIST v1.1 — Time Frame: Approximately within 36 months
  • disease control rate (DCR) assessed according to RECIST v1.1 — Time Frame: Approximately within 36 months
  • duration of response (DOR) assessed according to RECIST v1.1 — Time Frame: Approximately within 36 months
  • time to response (TTR) assessed according to RECIST v1.1 — Time Frame: Approximately within 36 months
  • Evaluate the overall survival (OS) — Time Frame: Approximately within 36 months
  • Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment — Time Frame: Approximately within 36 months
  • Characterize the PK parameter AUC — Time Frame: Approximately within 36 months

    steady-state area under curve (AUC)

  • Characterize the PK parameter Cmax — Time Frame: Approximately within 36 months

    peak concentration (Cmax)

Where to Participate

This trial is recruiting at 82 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 82 Facilities & Contact Sites
Anhui Tumour Hospital
Hefei, Anhui, China
Status: Open
The first affiliated hospital of Anhui Medical University
Hefei, Anhui, China
Status: Open
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Status: Opening Soon
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Status: Open
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Status: Opening Soon
Peking University Third Hospital
Beijing, Beijing Municipality, China
Status: Open
Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
Chongqing, Chongqing Municipality, China
Status: Opening Soon
Chongqing University Affiliated Tumor Hospital
Chongqing, Chongqing Municipality, China
Status: Open
The first affiliated hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Status: Opening Soon
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Status: Opening Soon
Xinqiao Hospital of AMU
Chongqing, Chongqing Municipality, China
Status: Open
Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Status: Open
Fujian Tumor Hospital
Fuzhou, Fujian, China
Status: Open
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Opening Soon
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Status: Open
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Status: Open
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Status: Opening Soon
Meizhou People's Hospital
Meizhou, Guangdong, China
Status: Open
Shantou University Medical College Tumour Hospital
Shantou, Guangdong, China
Status: Open
Guilin Medical College Second Affiliated Hospital
Guilin, Guangxi, China
Status: Open
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Status: Open
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi, China
Status: Open
The People's Hospital of Guangxi
Nanning, Guangxi, China
Status: Open
Harbin Medical university cancer hospital
Harbin, Heilongjiang, China
Status: Open
The First Affiliated Hospital Of Henan University&Technology
Luoyang, Henan, China
Status: Opening Soon
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Status: Open
Xinxiang Medical University No.1 Affiliated Hospital
Xinxiang, Henan, China
Status: Open
He'nan Cancer Hospital South Gate
Zhengzhou, Henan, China
Status: Open
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Status: Open
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Status: Open
The First Peoples Hospital of Jingzhou
Jingzhou, Hubei, China
Status: Open
Hubei Cancer Hospital
Wuhan, Hubei, China
Status: Open
Tongji Hospital
Wuhan, Hubei, China
Status: Open
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei, China
Status: Opening Soon
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Status: Open
Xiangyang Central Hospital
Xiangyang, Hubei, China
Status: Opening Soon
Hu'nan Province Cancer Hospital
Changsha, Hunan, China
Status: Open
Hunan Provincial People's Hospital
Changsha, Hunan, China
Status: Open
Xiangya hospital Central South University
Changsha, Hunan, China
Status: Open
The Third People's Hospital of Hunan Province
Yueyang, Hunan, China
Status: Open
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Status: Opening Soon
The Affiliated Hospital of Xuzhou medical University
Xuzhou, Jiangsu, China
Status: Open
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Status: Open
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Status: Opening Soon
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Status: Opening Soon
The Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
Status: Opening Soon
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Status: Open
Jilin Provincial Cancer Hospital
Changchun, Jilin, China
Status: Open
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Status: Open
The second Hospital of Dalian Medical University
Dalian, Liaoning, China
Status: Opening Soon
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, China
Status: Opening Soon
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Status: Open
The First Hospital of China Medical University Physical Examination Center
Shenyang, Liaoning, China
Status: Opening Soon
Shandong Cancer Hospital
Jinan, Shandong, China
Status: Open
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Status: Open
Shandong Cancer Hospital
Jinan, Shandong, China
Status: Opening Soon
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Status: Opening Soon
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Status: Opening Soon
Linyi Cancer hospital
Linyi, Shandong, China
Status: Open
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Status: Open
Weifang People's Hospital
Weifang, Shandong, China
Status: Opening Soon
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Status: Open
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Status: Opening Soon
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Status: Opening Soon
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Status: Opening Soon
The Affiliated Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Status: Opening Soon
The No.10 Peoples Hospital
Shanghai, Shanghai Municipality, China
Status: Open
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Status: Opening Soon
The First Affiliated Hospital Of Xi'an JiaoTong University
Xian, Shanxi, China
Status: Opening Soon
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Status: Open
SiChuan Cancer Hospital
Chengdu, Sichuan, China
Status: Opening Soon
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Status: Opening Soon
West China Hospital,Sichuan Universtiy
Chengdu, Sichuan, China
Status: Opening Soon
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Status: Opening Soon
Yunnan Tumor Hospital
Kunming, Yunnan, China
Status: Open
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
Status: Opening Soon
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Opening Soon
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Status: Opening Soon
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Status: Open
Zhejiang University Medical College Affiliated No.1 Hospital
Hangzhou, Zhejiang, China
Status: Open
Yiwu Central Hospital
Jinhua, Zhejiang, China
Status: Open
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
Status: Open
Trial Design & Scientific Setup
Allocation
non_randomized
Intervention Model
single group
Primary Purpose
treatment
Masking
none
Sponsoring Teams & Contacts
Lead Sponsoring Institution
MediLink Therapeutics (Suzhou) Co., Ltd.
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View Official Medical/Scientific Title

A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors

A Study of YL202 in Selected Patients With Advanced Solid Tumors — NCT06107686