Actively Recruiting
A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-11-26
200
Participants Needed
82
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YL202 in a multicenter, open-label phase II study in China to understand its effects on patients with advanced solid tumors such as non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, colorectal cancer, HER2-positive gastric cancer, cervical cancer, and ovarian cancer. The study aims to assess the efficacy, safety, and pharmacokinetic characteristics of YL202 in these patients. Patients will receive YL202 as an intravenous infusion, delivered as a lyophilized powder at a dose of 200 mg per vial. The treatment is given once every three weeks for locally advanced or metastatic tumors, with separate groups for different cancer types including NSCLC, breast cancer, HNSCC, and other locally advanced cancers. Each infusion lasts approximately 60 minutes. Participants will undergo evaluations including tumor response assessments according to RECIST v1.1 criteria, safety monitoring for adverse events, and pharmacokinetic analyses over approximately 36 months. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, and overall survival. Tumor tissue samples and other clinical data will also be collected to analyze treatment effects and biomarker relationships. Participants are expected to comply with scheduled visits and procedures throughout the study.
CONDITIONS
Brief Title
A Study of YL202 in Selected Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aware of trial information and voluntarily signed informed consent
- Aged 18 to 75 years
- Histologically or cytologically confirmed advanced NSCLC, breast cancer, HNSCC, or other locally advanced or metastatic solid tumors including colorectal, HER2-positive gastric, cervical, ovarian cancers
- At least one measurable extracranial lesion by RECIST 1.1
- Able to provide archived or fresh tumor tissue samples
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function within 7 days before first dose
- Female participants of childbearing potential agree to effective contraception during study and 6 months after last dose; male participants agree to effective contraception during study and 6 months after last dose
- Expected survival of at least 3 months
- Capable and willing to comply with study visits and procedures
You will not qualify if you...
- Prior therapy targeting HER3 including antibodies, ADCs, CAR-T, or similar drugs
- Intolerance to topoisomerase I inhibitors or ADC therapies containing them
- Currently participating in another interventional clinical study (except observational or follow-up period)
- Insufficient washout period from previous anti-tumor therapy before first dose
- Major surgery within 4 weeks before first dose or planned during study
- Prior allogeneic bone marrow or solid organ transplantation
- Use of systemic steroids (>10 mg prednisone or equivalent) or immunosuppressive treatment within 2 weeks before first dose
- Receipt or planned receipt of live vaccines within 4 weeks before or during study
- Meningeal metastasis or cancerous meningitis
- Brain metastasis or spinal cord compression
- Uncontrolled or significant cardiovascular diseases
- Significant complicated pulmonary disorders
- Diagnosis of Gilbert syndrome
- Uncontrolled third-space effusion requiring repeated drainage
- Recent gastrointestinal perforation/fistula or active gastrointestinal diseases prone to bleeding or perforation
- Serious infection before first dose
- Known HIV infection
- Active hepatitis B or C infection
- History of other primary malignancies within 5 years before first dose
- Unresolved toxicity from prior anti-tumor therapy
- Severe hypersensitivity to study drug ingredients or similar monoclonal antibodies
- Pregnant or lactating women
- Medical or social conditions affecting consent, participation, or study result interpretation including mental illness or substance abuse as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive YL202 through intravenous infusion once every 3 weeks as a treatment cycle for their advanced solid tumors.
Visits every 3 weeks for infusion
Trial Site Locations
Total: 82 locations
1
Anhui Tumour Hospital
Hefei, Anhui, China
Actively Recruiting
2
The first affiliated hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
3
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
4
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Actively Recruiting
5
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
6
Peking University Third Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
7
Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
8
Chongqing University Affiliated Tumor Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
9
The first affiliated hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
10
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
11
Xinqiao Hospital of AMU
Chongqing, Chongqing Municipality, China
Actively Recruiting
12
Xinqiao Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
13
Fujian Tumor Hospital
Fuzhou, Fujian, China
Actively Recruiting
14
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Not Yet Recruiting
15
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
16
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
17
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Not Yet Recruiting
18
Meizhou People's Hospital
Meizhou, Guangdong, China
Actively Recruiting
19
Shantou University Medical College Tumour Hospital
Shantou, Guangdong, China
Actively Recruiting
20
Guilin Medical College Second Affiliated Hospital
Guilin, Guangxi, China
Actively Recruiting
21
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Actively Recruiting
22
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi, China
Actively Recruiting
23
The People's Hospital of Guangxi
Nanning, Guangxi, China
Actively Recruiting
24
Harbin Medical university cancer hospital
Harbin, Heilongjiang, China
Actively Recruiting
25
The First Affiliated Hospital Of Henan University&Technology
Luoyang, Henan, China
Not Yet Recruiting
26
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Actively Recruiting
27
Xinxiang Medical University No.1 Affiliated Hospital
Xinxiang, Henan, China
Actively Recruiting
28
He'nan Cancer Hospital South Gate
Zhengzhou, Henan, China
Actively Recruiting
29
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Actively Recruiting
30
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
31
The First Peoples Hospital of Jingzhou
Jingzhou, Hubei, China
Actively Recruiting
32
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
33
Tongji Hospital
Wuhan, Hubei, China
Actively Recruiting
34
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei, China
Not Yet Recruiting
35
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
36
Xiangyang Central Hospital
Xiangyang, Hubei, China
Not Yet Recruiting
37
Hu'nan Province Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
38
Hunan Provincial People's Hospital
Changsha, Hunan, China
Actively Recruiting
39
Xiangya hospital Central South University
Changsha, Hunan, China
Actively Recruiting
40
The Third People's Hospital of Hunan Province
Yueyang, Hunan, China
Actively Recruiting
41
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Not Yet Recruiting
42
The Affiliated Hospital of Xuzhou medical University
Xuzhou, Jiangsu, China
Actively Recruiting
43
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Actively Recruiting
44
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Not Yet Recruiting
45
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Not Yet Recruiting
46
The Affiliated Hospital of NanChang University
Nanchang, Jiangxi, China
Not Yet Recruiting
47
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Actively Recruiting
48
Jilin Provincial Cancer Hospital
Changchun, Jilin, China, 215000
Actively Recruiting
49
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
50
The second Hospital of Dalian Medical University
Dalian, Liaoning, China
Not Yet Recruiting
51
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, China, 530021
Not Yet Recruiting
52
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
53
The First Hospital of China Medical University Physical Examination Center
Shenyang, Liaoning, China
Not Yet Recruiting
54
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
55
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, China
Actively Recruiting
56
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
57
Shandong Provincial Public Health Clinical Center
Jinan, Shandong, China
Not Yet Recruiting
58
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Not Yet Recruiting
59
Linyi Cancer hospital
Linyi, Shandong, China
Actively Recruiting
60
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
61
Weifang People's Hospital
Weifang, Shandong, China
Not Yet Recruiting
62
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
63
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
64
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
65
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
66
The Affiliated Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
67
The No.10 Peoples Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
68
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
69
The First Affiliated Hospital Of Xi'an JiaoTong University
Xian, Shanxi, China
Not Yet Recruiting
70
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Actively Recruiting
71
SiChuan Cancer Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
72
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
73
West China Hospital,Sichuan Universtiy
Chengdu, Sichuan, China
Not Yet Recruiting
74
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Not Yet Recruiting
75
Yunnan Tumor Hospital
Kunming, Yunnan, China
Actively Recruiting
76
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
77
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
78
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
79
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
80
Zhejiang University Medical College Affiliated No.1 Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
81
Yiwu Central Hospital
Jinhua, Zhejiang, China
Actively Recruiting
82
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here