Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

200

participants targeted

Target at P75+ for phase_2

Timeline

30mo left

Started Dec 2023

Longer than P75 for phase_2

Geographic Reach

1 country

82 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

Study Progress49%

Dec 2023Nov 2028

First Submitted

Initial submission to the registry

October 20, 2023

Completed

10 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed

2 months until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

October 20, 2023

Last Update Submit

November 20, 2025

Conditions

NSCLC Breast Cancer HNSCC Locally Advanced or Metastatic Solid Tumors

Keywords

Antibody-drug conjugate

Outcome Measures

Primary Outcomes (2)

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 Outcomes (17)

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
+12 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Drug: YL202 should be intravenously infused

Interventions

YL202 should be intravenously infusedDRUG

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

Corhort ACorhort BCorhort CCorhort D

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MediLink Therapeutics (Suzhou) Co., Ltd.lead

Study Sites (82)

Anhui Tumour Hospital

Hefei, Anhui, China

RECRUITING

The first affiliated hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Beijing Cancer hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Chongqing University Affiliated Tumor Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The first affiliated hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Xinqiao Hospital of AMU

Chongqing, Chongqing Municipality, China

RECRUITING

Xinqiao Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Fujian Tumor Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

NOT YET RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Meizhou People's Hospital

Meizhou, Guangdong, China

RECRUITING

Shantou University Medical College Tumour Hospital

Shantou, Guangdong, China

RECRUITING

Guilin Medical College Second Affiliated Hospital

Guilin, Guangxi, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Guangxi Medical University Affiliated Tumour Hospital

Nanning, Guangxi, China

RECRUITING

The People's Hospital of Guangxi

Nanning, Guangxi, China

RECRUITING

Harbin Medical university cancer hospital

Harbin, Heilongjiang, China

RECRUITING

The First Affiliated Hospital Of Henan University&Technology

Luoyang, Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

RECRUITING

Xinxiang Medical University No.1 Affiliated Hospital

Xinxiang, Henan, China

RECRUITING

He'nan Cancer Hospital South Gate

Zhengzhou, Henan, China

RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The First Peoples Hospital of Jingzhou

Jingzhou, Hubei, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Union Hospital Tongji Medical College HuaZhong University of Science Technology

Wuhan, Hubei, China

NOT YET RECRUITING

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

NOT YET RECRUITING

Hu'nan Province Cancer Hospital

Changsha, Hunan, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

RECRUITING

Xiangya hospital Central South University

Changsha, Hunan, China

RECRUITING

The Third People's Hospital of Hunan Province

Yueyang, Hunan, China

RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou medical University

Xuzhou, Jiangsu, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

RECRUITING

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

NOT YET RECRUITING

The Affiliated Hospital of NanChang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

The Third Hospital of Nanchang

Nanchang, Jiangxi, China

RECRUITING

Jilin Provincial Cancer Hospital

Changchun, Jilin, 215000, China

RECRUITING

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

The second Hospital of Dalian Medical University

Dalian, Liaoning, China

NOT YET RECRUITING

Fukuang General Hospital of Liaoning Health Industry Group

Fushun, Liaoning, 530021, China

NOT YET RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

RECRUITING

The First Hospital of China Medical University Physical Examination Center

Shenyang, Liaoning, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Jinan Central Hospital Affiliated to Shandong University

Jinan, Shandong, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Shandong Provincial Public Health Clinical Center

Jinan, Shandong, China

NOT YET RECRUITING

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

NOT YET RECRUITING

Linyi Cancer hospital

Linyi, Shandong, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Weifang People's Hospital

Weifang, Shandong, China

NOT YET RECRUITING

Huashan Hospital affiliated to Fudan University