NSCLCPhase 2NCT06107686
A Study of YL202 in Selected Patients With Advanced Solid Tumors
A Phase 2 study testing YL202 should be intravenously infused in people with NSCLC and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 82 sites in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Breast Cancer, HNSCC
- What is being tested?
- YL202 should be intravenously infused
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 82 sitesChina
- Study dates
- 15 Dec 2023to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
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- 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.
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- 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.
Trial locations and contacts
82 sites in 1 country. Contact the study team or a site near you to ask about taking part.
82 sites in 1 country
China82 sites, 82 recruiting
- Recruiting
Beijing Cancer hospital
Beijing, Beijing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Clinical Operation derictor, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Jilin Provincial Cancer Hospital
Changchun, Jilin, 215000
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Hu'nan Province Cancer Hospital
Changsha, Hunan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Xiangya hospital Central South University
Changsha, Hunan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
SiChuan Cancer Hospital
Chengdu, Sichuan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
West China Hospital,Sichuan Universtiy
Chengdu, Sichuan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army
Chongqing, Chongqing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Chongqing University Affiliated Tumor Hospital
Chongqing, Chongqing Municipality
Coordinator Clincial operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The first affiliated hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Xinqiao Hospital of AMU
Chongqing, Chongqing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Xinqiao Hospital
Chongqing, Chongqing Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The second Hospital of Dalian Medical University
Dalian, Liaoning
Coordinator, clinicaltrials@medilinkthera.com
- Not yet recruiting
Fukuang General Hospital of Liaoning Health Industry Group
Fushun, Liaoning, 530021
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Fujian Tumor Hospital
Fuzhou, Fujian
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Guilin Medical College Second Affiliated Hospital
Guilin, Guangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University school of Medicine
Hangzhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
ZheJiang Cancer Hospital
Hangzhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Zhejiang Province People's Hospital
Hangzhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Zhejiang Province People's Hospital
Hangzhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Zhejiang University Medical College Affiliated No.1 Hospital
Hangzhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Harbin Medical university cancer hospital
Harbin, Heilongjiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Anhui Tumour Hospital
Hefei, Anhui
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The first affiliated hospital of Anhui Medical University
Hefei, Anhui
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shandong Provincial Public Health Clinical Center
Jinan, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The First Peoples Hospital of Jingzhou
Jingzhou, Hubei
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Yiwu Central Hospital
Jinhua, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Yunnan Tumor Hospital
Kunming, Yunnan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Linyi Cancer hospital
Linyi, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The First Affiliated Hospital Of Henan University&Technology
Luoyang, Henan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Meizhou People's Hospital
Meizhou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Affiliated Hospital of NanChang University
Nanchang, Jiangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The Third Hospital of Nanchang
Nanchang, Jiangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Guangxi Medical University Affiliated Tumour Hospital
Nanning, Guangxi
Coordinator RA, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The People's Hospital of Guangxi
Nanning, Guangxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
Coordinator Clincial operation director, 051262858368, clinicaltrials@medilinkthera.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
Coordinator Clinial Operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Affiliated Huashan Hospital of Fudan University
Shanghai, Shanghai Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The No.10 Peoples Hospital
Shanghai, Shanghai Municipality
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Shantou University Medical College Tumour Hospital
Shantou, Guangdong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The First Hospital of China Medical University Physical Examination Center
Shenyang, Liaoning
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Weifang People's Hospital
Weifang, Shandong
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Tongji Hospital
Wuhan, Hubei
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
The First Affiliated Hospital Of Xi'an JiaoTong University
Xian, Shanxi
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei
Coordinator, clinicaltrials@medilinkthera.com
- Recruiting
Xinxiang Medical University No.1 Affiliated Hospital
Xinxiang, Henan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The Affiliated Hospital of Xuzhou medical University
Xuzhou, Jiangsu
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The Third People's Hospital of Hunan Province
Yueyang, Hunan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
He'nan Cancer Hospital South Gate
Zhengzhou, Henan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
Henan Provincial Chest Hospital
Zhengzhou, Henan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Coordinator Clinical operation director, +86 0512-62858368, clinicaltrials@medilinkthera.com
About this study
Official title: 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.
Read the 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.
- Being tested
- YL202 should be intravenously infused
- Keywords
- Antibody-drug conjugate
- Medical subject headings
- Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL202 should be intravenously infusedDrug
For each patient, YL202 should be intravenously infused over 60±10 min.
| Study group | Role | What they receive |
|---|---|---|
| Corhort A | Experimental | 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. Receives: Drug: YL202 should be intravenously infused |
| Corhort B | Experimental | 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. Receives: Drug: YL202 should be intravenously infused |
| Corhort C | Experimental | 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. Receives: Drug: YL202 should be intravenously infused |
| Corhort D | Experimental | 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. Receives: Drug: YL202 should be intravenously infused |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: By the end of trial date, approximately within 36 months
Determination of the recommended dose of YL202 in the pivotal clinical study
Measured: By the end of trial date, approximately within 36 months
Secondary outcomes (17)
Progression-free survival (PFS) assessed according to RECIST v1.1
Measured: approximately within 36 months
Clinical benefit rate (CBR) assessed according to RECIST v1.1
Measured: approximately within 36 months
depth of response (DpR) assessed according to RECIST v1.1
Measured: Approximately within 36 months
disease control rate (DCR) assessed according to RECIST v1.1
Measured: Approximately within 36 months
duration of response (DOR) assessed according to RECIST v1.1
Measured: Approximately within 36 months
time to response (TTR) assessed according to RECIST v1.1
Measured: Approximately within 36 months
Evaluate the overall survival (OS)
Measured: Approximately within 36 months
Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment
Measured: Approximately within 36 months
Characterize the PK parameter AUC
steady-state area under curve (AUC)
Measured: Approximately within 36 months
Characterize the PK parameter Cmax
peak concentration (Cmax)
Measured: Approximately within 36 months
Characterize the PK parameter Ctrough
trough concentration (Ctrough)
Measured: Approximately within 36 months
Characterize the PK parameter CL
clearance (CL)
Measured: Approximately within 36 months
Characterize the PK parameter Vd
volume of distribution (Vd)
Measured: Approximately within 36 months
Characterize the PK parameter t1/2
half-life (t1/2)
Measured: Approximately within 36 months
Incidence of anti-YL202 antibody
Measured: approximately within 36 months
Establish a POP PK model for exposure-response relationship analysis
Measured: approximately within 36 months
Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate
Measured: approximately within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Dec 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107686
- Sponsor's protocol ID
- YL202-CN-201-01
- Status last verified
- Nov 2025
- First submitted
- 20 Oct 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06107686
- Acronym / sponsor ID
- YL202-CN-201-01
- Keywords
- Antibody-drug conjugate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Corhort A | Experimental | Drug: YL202 should be intravenously infusedYL202 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. |
| Corhort B | Experimental | Drug: YL202 should be intravenously infusedYL202 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. |
| Corhort C | Experimental | Drug: YL202 should be intravenously infusedYL202 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. |
| Corhort D | Experimental | Drug: YL202 should be intravenously infusedYL202 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL202 should be intravenously infusedFor each patient, YL202 should be intravenously infused over 60±10 min. | Drug | Corhort A, Corhort B, Corhort C, Corhort D |
Primary outcome
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
17 secondary outcomes
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
Characterize the PK parameter Cmax
Time frame: Approximately within 36 months
Characterize the PK parameter Ctrough
Time frame: Approximately within 36 months
Characterize the PK parameter CL
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
Time frame: Approximately within 36 months
Incidence of anti-YL202 antibody
Time frame: approximately within 36 months
Establish a POP PK model for exposure-response relationship analysis
Time frame: approximately within 36 months
Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate
Time frame: approximately within 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The first affiliated hospital of Anhui Medical University
Hefei, China
The Second Hospital of Anhui Medical University
Hefei, China
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YL202 should be intravenously infused in people with NSCLC and Breast Cancer, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 82 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR assessed according to RECIST v1.1 (time frame: By the end of trial date, approximately within 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.