TrialPath
Recruiting

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

NCT07169994 · MediLink Therapeutics (Suzhou) Co., Ltd.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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
About this study
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
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.
Study design
Enrollment target: 414 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-02
Estimated completion: 2027-11-30
Last updated: 2025-09-12
Interventions
Drug: YL202 for injection; Toripalimab injectionDrug: YL202 for injection; Furmonertinib Mesilate Tablets
Primary outcomes
  • Nature and frequency of dose-limiting toxicity (DLT) (21 days after the first dose was administered to each subject.)
  • Nature and frequency of adverse events (AEs) (42 days after the end of treatment (EOT).)
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd. · industry
Contacts & investigators
ContactNing Wang, MM · contact · info@medilinkthera.com · +86 0512-62858368
All locations (20)
Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)Not Yet Recruiting
Hefei, Anhui, China
Fujian Cancer HospitalNot Yet Recruiting
Fuzhou, Fujian, China
Sun Yat-sen University Cancer CenterNot Yet Recruiting
Guangzhou, Guangdong, China
Meizhou People's Hospital(Huangtang Hospital)Meizhou Academy of Medical SciencesNot Yet Recruiting
Meizhou, Guangdong, China
Ghang xi Medical University Cancer HospitalNot Yet Recruiting
Nanning, Guangxi, China
Affiliated Hospital Of Hebei UniversityNot Yet Recruiting
Baoding, Hebei, China
Harbin Medical University Cancer HospitalNot Yet Recruiting
Harbin, Heilongjiang, China
Anyang Cancer HospitalNot Yet Recruiting
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science and TechnologyNot Yet Recruiting
Luoyang, Henan, China
Xiangyang Central HospitalNot Yet Recruiting
Xiangyang, Hubei, China
The First People's Hospital of Changde CityNot Yet Recruiting
Changde, Hunan, China
Jiangsu Province Hospital(The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)Not Yet Recruiting
Nanjing, Jiangsu, China
Jiangxi Cancer HospitalNot Yet Recruiting
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital Dalian UniversityNot Yet Recruiting
Dalian, Liaoning, China
Liaoning cancer hospital &instituteNot Yet Recruiting
Shenyang, Liaoning, China
Affiliated Zhongshan Hospital Dalian UniversityNot Yet Recruiting
Jinan, Shandong, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China
Shanxi Cancer HospitalNot Yet Recruiting
Taiyuan, Shanxi, China
Sichuan Academy of Medical Sciences&Sichuan Provincial People's HospitalNot Yet Recruiting
Sichuan, Sichuan, China
Tianjin Cancer Hospital Airport HospitalNot Yet Recruiting
Tianjin, Tianjin Municipality, China