YL202 combined with immunotherapy or targeted therapy for advanced solid tumors

A Multi-center, Open-Label, Phase Ib/II Study of YL202 in Combination With Anti-tumor Therapy to Evaluate the Safety, Tolerability, and Efficacy in Patients With Advanced Solid Tumors

This trial tests whether adding YL202 to other anti-tumor treatments helps adults with advanced solid tumors (including breast cancer and non‑small cell lung cancer) tolerate therapy and control tumor growth.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 414 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T, chimeric antigen receptor, immunotherapy, prednisone
• Locations: 20 sites (Hefei, Anhui and 19 other locations)
• Trial ID: NCT07169994 on ClinicalTrials.gov

What this trial studies

This multicenter, open‑label phase Ib/II trial gives YL202 in combination with other anti‑tumor agents to adults with advanced solid tumors to define safe dosing and look for anti‑tumor activity. Phase Ib uses dose‑escalation cohorts to determine safety and tolerability when YL202 is combined with agents such as toripalimab or furmonertinib, and phase II expands select cohorts to measure tumor response and duration of benefit. Eligible patients are 18–75 years old with ECOG 0–1, adequate organ and marrow function, at least one extracranial measurable lesion, and available archival tumor tissue. The trial is open at several hospitals in China and collects safety labs, adverse event data, and tumor imaging at scheduled visits.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced solid tumors (including breast cancer or NSCLC), ECOG performance status 0–1, adequate organ function, at least one extracranial measurable lesion, prior standard treatment or no prior metastatic therapy, and available archival FFPE tissue are the intended participants.

Not a fit: Patients previously treated with HER3‑targeting drugs, those intolerant to topoisomerase I inhibitor–based ADCs, people with poor performance status (ECOG >1), or those unable to attend required site visits are unlikely to benefit from joining.

Why it matters

Potential benefit: If successful, the combination could improve tumor control or extend the time patients live without disease worsening compared with available options.

How similar studies have performed: Antibody‑drug conjugates and combinations with PD‑1 inhibitors or EGFR TKIs have produced promising early signals in some cancers, but HER3‑targeted approaches are still emerging and lack broad late‑stage confirmation.

Eligibility criteria

Inclusion Criteria:

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

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.

Where this trial is running

Hefei, Anhui and 19 other locations

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

Study contacts

• Study coordinator: Ning Wang, MM

Conditions Advanced Solid Tumors; Breast Cancer; Non Small Cell Lung Cancer