A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, Breast Cancer, Non Small Cell Lung Cancer

In brief

This is a multicenter, open-label, phase Ib/II study of YL202 in combination with other anti-tumor therapies to Evaluate the Safety, Tolerability, and Efficacy in Patients with Advanced Solid Tumors

Key facts

Study ID: NCT07169994
Run by: MediLink Therapeutics (Suzhou) Co., Ltd.
People needed: 414
Starts: 2025-09-02
Expected to finish: 2027-11-30
Last updated by the study team: 2025-09-12

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Informed of the study before the start of the study and voluntarily sign their name and date in the informed consent form (ICF)
Able and willing to comply with protocol visits and procedures
Aged between 18 to 75 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
Previously treated by standard treatment or have not been treated for metastatic setting;
Adequate organ and bone marrow function.
Have at least 1 extracranial measurable tumor lesion.
Adequate archival formalin-fixed paraffin embedded （FFPE） tissue from prior biopsy.

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.
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.

Where it is running

Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Fujian Cancer Hospital — Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical Sciences — Meizhou, Guangdong, China
Ghang xi Medical University Cancer Hospital — Nanning, Guangxi, China
Affiliated Hospital Of Hebei University — Baoding, Hebei, China
Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
Anyang Cancer Hospital — Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China
Xiangyang Central Hospital — Xiangyang, Hubei, China
The First People's Hospital of Changde City — Changde, Hunan, China
Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital) — Nanjing, Jiangsu, China
Jiangxi Cancer Hospital — Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital Dalian University — Dalian, Liaoning, China
Liaoning cancer hospital &institute — Shenyang, Liaoning, China
Affiliated Zhongshan Hospital Dalian University — Jinan, Shandong, China
Shanxi Cancer Hospital — Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital — Sichuan, Sichuan, China
Anhui Provincial Hospital(The First Affiliated Hospital of Ustc) — Hefei, Anhui, China
Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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