A Study of YL202 in Selected Patients With Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; NSCLC; HNSCC; Locally Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: YL202 should be intravenously infused

Detailed Description

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Hefei, Anhui, China
      • Not yet recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Coordinator
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Tumour Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Beijing, Beijing, China
      • Not yet recruiting
      • Beijing Tsinghua Chang Gung Hospital
      • Contact: Coordinator
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
      • Contact: Dezhi Clinical Operation derictor; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Coordinator
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Coordinator
    • Chongqing, Chongqing, China
      • Recruiting
      • Xinqiao Hospital of AMU
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
      • Contact: Coordinator
    • Chongqing, Chongqing, China
      • Recruiting
      • Chongqing University Affiliated Tumor Hospital
      • Contact: Coordinator Clincial operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The Third Affiliated Hospital of the Chinese Army Medical University of the People's Liberation Army
      • Contact: Coordinator
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fujian Tumor Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Coordinator
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Coordinator
    • Meizhou, Guangdong, China
      • Not yet recruiting
      • Meizhou People's Hospital
      • Contact: Coordinator
    • Shantou, Guangdong, China
      • Recruiting
      • Shantou University Medical College Tumour Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Guangxi
    • Guilin, Guangxi, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Guilin Medical University
      • Contact: Coordinator
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Medical University Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Nanning, Guangxi, China
      • Recruiting
      • Guangxi Medical University Affiliated Tumour Hospital
      • Contact: Coordinator RA; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Nanning, Guangxi, China
      • Recruiting
      • The People's Hospital of Guangxi
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Henan
    • Luoyang, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital Of Henan University&Technology
      • Contact: Coordinator
    • Nanyang, Henan, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanyang Medical College
      • Contact: Coordinator
    • Xinxiang, Henan, China
      • Recruiting
      • Xinxiang Medical University No.1 Affiliated Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Zhengzhou, Henan, China
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial Chest Hospital
      • Contact: Coordinator
    • Zhengzhou, Henan, China
      • Recruiting
      • He'nan Cancer Hospital South Gate
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Hubei
    • Jingzhou, Hubei, China
      • Recruiting
      • The First Peoples Hospital of Jingzhou
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Union Hospital Tongji Medical College HuaZhong University of Science Technology
      • Contact: Coordinator
    • Xiangyang, Hubei, China
      • Not yet recruiting
      • Xiangyang Central Hospital
      • Contact: Coordinator
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital Central South University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Changsha, Hunan, China
      • Not yet recruiting
      • Hunan Provincial People's Hospital
      • Contact: Coordinator
    • Changsha, Hunan, China
      • Recruiting
      • Hu'nan Province Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Yueyang, Hunan, China
      • Not yet recruiting
      • The Third People's Hospital of Hunan Province
      • Contact: Coordinator
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Not yet recruiting
      • The Second Affiliated Hospital of Soochow University
      • Contact: Coordinator
    • Xuzhou, Jiangsu, China
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical University
      • Contact: Coordinator
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Xuzhou Central Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Not yet recruiting
      • First Affiliated hospital of Gannan Medical University
      • Contact: Coordinator
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • Jiangxi Cancer Hospital
      • Contact: Coordinator
    • Nanchang, Jiangxi, China
      • Recruiting
      • The Third Hospital of Nanchang
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The Affiliated Hospital of NanChang University
      • Contact: Coordinator
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • China-Japan Union Hospital of Jilin University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Changchun, Jilin, China, 215000
      • Recruiting
      • Jilin Provincial Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Liaoning
    • Dalian, Liaoning, China
      • Not yet recruiting
      • The Second Hospital of Dalian Medical University
      • Contact: Coordinator
    • Fushun, Liaoning, China
      • Not yet recruiting
      • Fukuang General Hospital of Liaoning Health Industry Group
      • Contact: Coordinator
    • Shenyang, Liaoning, China
      • Recruiting
      • Liaoning cancer Hospital & Institute
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • The First Hospital of China Medical University Physical Examination Center
      • Contact: Coordinator
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Jinan, Shandong, China
      • Recruiting
      • Jinan Central Hospital Affiliated to Shandong University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Cancer Hospital
      • Contact: Coordinator
    • Jinan, Shandong, China
      • Not yet recruiting
      • Shandong Provincial Public Health Clinical Center
      • Contact: Coordinator
    • Jining, Shandong, China
      • Not yet recruiting
      • Affiliated Hospital of Jining Medical University
      • Contact: Coordinator
    • Linyi, Shandong, China
      • Recruiting
      • LinYi Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Qingdao, Shandong, China
      • Recruiting
      • The Affiliated Hospital Of Qingdao University
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Weifang, Shandong, China
      • Not yet recruiting
      • Weifang people's Hospital
      • Contact: Coordinator
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Huashan Hospital Affiliated to Fudan University
      • Contact: Coordinator Clinial Operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai General Hospital
      • Contact: Coordinator
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Ninth People's Hospital
      • Contact: Coordinator
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Coordinator
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • The Affiliated Huashan Hospital of Fudan University
      • Contact: Coordinator
    • Shanghai, Shanghai, China
      • Recruiting
      • The No.10 Peoples Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Province Cancer Hospital
      • Contact: Coordinator
    • Xian, Shanxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Coordinator
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Cancer Hospital
      • Contact: Coordinator
    • Chengdu, Sichuan, China
      • Recruiting
      • Sichuan Cancer Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital of Sichuan University
      • Contact: Coordinator
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital,Sichuan Universtiy
      • Contact: Coordinator
  • Xinjiang
    • Urumqi, Xinjiang, China
      • Not yet recruiting
      • The Affiliated Cancer Hospital of XinJiang Medical University
      • Contact: Coordinator
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Yunnan Tumor Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The second affiliated hospital of zhejiang university school of medicine
      • Contact: Coordinator
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
      • Contact: Coordinator
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang University Medical College Affiliated No.1 Hospital
      • Contact: Coordinator
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Province People's Hospital
      • Contact: Coordinator
    • Jinhua, Zhejiang, China
      • Recruiting
      • Yiwu Central Hospital
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com
    • Taizhou, Zhejiang, China
      • Recruiting
      • Taizhou Hospital of Zhejiang
      • Contact: Coordinator Clinical operation director; Phone Number: +86 0512-62858368; Email: RA@medilinkthera.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. 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).
2. Subjects aged from 18-75 (inclusive) years.
3. 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..
4. At least one extracranial measurable lesion according to RECIST 1.1.
5. Archived or fresh tumor tissue samples can be provided.
6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
7. The function of organs and bone marrow meets the requirements within 7 days before the first dose.
8. 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.
9. With expected survival ≥ 3 months.
10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol.

Exclusion Criteria:

1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs).
2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors.
3. 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.
4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product.
5. 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.
6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation.
7. 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.
8. 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.
9. With meningeal metastasis or cancerous meningitis.
10. With brain metastasis or spinal cord compression.
11. Patients with uncontrolled or clinically significant cardiovascular diseases.
12. Clinically significant complicated pulmonary disorders.
13. Patients diagnosed with Gilbert syndrome.
14. Those with uncontrolled effusion in the third space requiring repeated drainage.
15. 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.
16. With serious infection before the first dose.
17. With known human immunodeficiency virus (HIV) infection.
18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product.
20. Unrelieved toxicity of previous anti-tumor therapy.
21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies.
22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose.
23. 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.

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corhort 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.	Drug: YL202 should be intravenously infused; For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort 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.	Drug: YL202 should be intravenously infused; For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort 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.	Drug: YL202 should be intravenously infused; For each patient, YL202 should be intravenously infused over 60±10 min.
Experimental: Corhort 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.	Drug: YL202 should be intravenously infused; For each patient, YL202 should be intravenously infused over 60±10 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR assessed according to RECIST v1.1	ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).	By the end of trial date, approximately within 36 months
Determination of the recommended dose of YL202 in the pivotal clinical study		By the end of trial date, approximately within 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) assessed according to RECIST v1.1		approximately within 36 months
Clinical benefit rate (CBR) assessed according to RECIST v1.1		approximately within 36 months
depth of response (DpR) assessed according to RECIST v1.1		Approximately within 36 months
disease control rate (DCR) assessed according to RECIST v1.1		Approximately within 36 months
duration of response (DOR) assessed according to RECIST v1.1		Approximately within 36 months
time to response (TTR) assessed according to RECIST v1.1		Approximately within 36 months
Evaluate the overall survival (OS)		Approximately within 36 months
Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment		Approximately within 36 months
Characterize the PK parameter AUC	steady-state area under curve (AUC)	Approximately within 36 months
Characterize the PK parameter Cmax	peak concentration (Cmax)	Approximately within 36 months
Characterize the PK parameter Ctrough	trough concentration (Ctrough)	Approximately within 36 months
Characterize the PK parameter CL	clearance (CL)	Approximately within 36 months
Characterize the PK parameter Vd	volume of distribution (Vd)	Approximately within 36 months
Characterize the PK parameter t1/2	half-life (t1/2)	Approximately within 36 months
Incidence of anti-YL202 antibody		approximately within 36 months
Establish a POP PK model for exposure-response relationship analysis		approximately within 36 months
Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate		approximately within 36 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Antibody-drug conjugate
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: YL202-CN-201-01

Drug and device information, study documents

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