> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-yl202-in-combination-with-other-anti-tumor-ffab80c8-f98a-4c3e-89eb-817a97ecb073 > Record changed: 2026-10-13 # A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors NCT07169994 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Participants 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Lead sponsor MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Start date 2025-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) Number of sites 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Title and summary **Summary** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Short title** A Study of YL202 in Combination With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Dates **Completion date** 2027-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **First posted** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Registry last updated** 2025-09-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Primary completion date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Start date** 2025-09-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Size and sites **Participants** 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Planned participants** 414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Number of sites** 20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Lead sponsor** MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Identifiers **Registry ID** NCT07169994 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **ClinicalTrials.gov ID** NCT07169994 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Outcomes ### Primary outcomes 1. Nature and frequency of dose-limiting toxicity (DLT) Timeframe: 21 days after the first dose was administered to each subject. The purpose of DLT is to find maximum tolerated dose (MTD). 2. Nature and frequency of adverse events (AEs) Timeframe: 42 days after the end of treatment (EOT). Nature and frequency of AEs with severity is aim to evaluate the safety of YL202 combination. ### Secondary outcomes 1. Objective response rate (ORR) Timeframe: Up to approximately 3 years. ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). 2. Characterize Pharmacokinetics (PK) parameter AUC Timeframe: Up to approximately 3 years The area under curve: AUC is the total amount of YL217 in bloodstream after drug administration. 3. Characterize Pharmacokinetics (PK) parameter Cmax Timeframe: Up to approximately 3 years Maximum concentration: The highest measured concentration of YL217 in the bloodstream. 4. Characterize Pharmacokinetics (PK) parameter Ctrough Timeframe: Up to approximately 3 years Trough concentration 5. Characterize Pharmacokinetics (PK) parameter Tmax Timeframe: Up to approximately 3 years Time to maximum observed concentration 6. Characterize Pharmacokinetics (PK) parameter CL Timeframe: Up to approximately 3 years Clearance： defined as the amount of drug removed from the bloodstream by the body per unit of time 7. Characterize Pharmacokinetics (PK) parameter Vd Timeframe: Up to approximately 3 years volume of distribution 8. Characterize Pharmacokinetics (PK) parameter t1/2 Timeframe: Up to approximately 3 years Half-life time：defined as the time it takes for the concentration of the drug in plasma or serum to be reduced by 50% 9. Immunogenicity endpoint: Incidence of anti-YL202 antibody (ADAs). Timeframe: Up to approximately 3 years The presence of ADAs in patients treated with YL202 will be assessed to evaluate immunogenicity. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Sites - Anhui Provincial Hospital(The First Affiliated Hospital of Ustc)Hefei, ChinaNot yet recruiting - Fujian Cancer HospitalFuzhou, ChinaNot yet recruiting - Sun Yat-sen University Cancer CenterGuangzhou, ChinaNot yet recruiting - Meizhou People's Hospital（Huangtang Hospital）Meizhou Academy of Medical SciencesMeizhou, ChinaNot yet recruiting - Ghang xi Medical University Cancer HospitalNanning, ChinaNot yet recruiting - Affiliated Hospital Of Hebei UniversityBaoding, ChinaNot yet recruiting - Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting - Anyang Cancer HospitalAnyang, ChinaNot yet recruiting - The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaNot yet recruiting - Xiangyang Central HospitalXiangyang, ChinaNot yet recruiting - The First People's Hospital of Changde CityChangde, ChinaNot yet recruiting - Jiangsu Province Hospital（The First Affiliated Hospital With Nanjing Medical University, Jiangsu Women And Children Health Hospital)Nanjing, ChinaNot yet recruiting - Jiangxi Cancer HospitalNanchang, ChinaNot yet recruiting - Affiliated Zhongshan Hospital Dalian UniversityDalian, ChinaNot yet recruiting - Liaoning cancer hospital &instituteShenyang, ChinaNot yet recruiting - Affiliated Zhongshan Hospital Dalian UniversityJinan, ChinaNot yet recruiting - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting - Shanxi Cancer HospitalTaiyuan, ChinaNot yet recruiting - Sichuan Academy of Medical Sciences&Sichuan Provincial People's HospitalSichuan, ChinaNot yet recruiting - Tianjin Cancer Hospital Airport HospitalTianjin, ChinaNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07169994) ## Related records ### Drugs (3) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) - [Firmonertinib mesylate](https://trialight.com/data/asset/firmonertinib-mesylate-ebbdcb6b-1812-4e52-aac8-773369fa8282.md) - [Toripalimab](https://trialight.com/data/asset/toripalimab-92e6b353-a6c4-4e1e-a99f-559038ba7177.md) ### Lead sponsors (1) - [MediLink Therapeutics (Suzhou) Co., Ltd.](https://trialight.com/data/company/medilink-therapeutics-suzhou-co-ltd-19ce5b89-575e-477f-bc72-fb89066b22b6.md) ### Conditions (3) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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