> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-yl242-in-subjects-with-advanced-solid-tumors-59d5e9fe-bb69-487e-a07f-1e512ec42f48 > Record changed: 2026-10-13 # A Study of YL242 in Subjects With Advanced Solid Tumors NCT07197827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Participants 424 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Lead sponsor MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Start date 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) Number of sites 15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Title and summary **Summary** This is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Short title** A Study of YL242 in Subjects With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Official title** A Phase 1/2, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL242 Monotherapy and Combinations in Advanced Solid Tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Dates **Completion date** 2028-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **First posted** 2025-09-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Registry last updated** 2025-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Primary completion date** 2028-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Start date** 2025-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Size and sites **Participants** 424 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Planned participants** 424 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Number of sites** 15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Lead sponsor** MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Identifiers **Registry ID** NCT07197827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **ClinicalTrials.gov ID** NCT07197827 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Outcomes ### Primary outcomes 1. Objective Response Rate (ORR) in Participants With Advanced Solid Malignant Tumors (Part 2, and 4-6) Timeframe: Approximately within 36 months Objective response rate (ORR) was defined as the proportion of participants who achieve either complete response \\\[CR\\\] or partial response \\\[PR\\\] per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 2. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) Timeframe: Baseline up to 42 days post last patients last dose, approximately within 36 months AEs will be collected systematically from signing of the informed consent form (ICF) through 42 days after last dose. ### Secondary outcomes 1. Area Under the Serum Concentration Time Curve (AUC) of YL242 Timeframe: Approximately within 36 months 2. Maximum Plasma Concentration (Cmax) of YL242 Timeframe: Approximately within 36 months 3. Time to Maximum Plasma Concentration (Tmax) of YL242 Timeframe: Approximately within 36 months 4. Incidence of anti-YL242 antibody Timeframe: Approximately within 36 months 5. Terminal Elimination Half-life (t1/2) of Serum YL242 Timeframe: Approximately within 36 months 6. Disease Control Rate (DCR) Timeframe: Approximately within 36 months Disease control rate (DCR) was calculated as the proportion of participants demonstrating complete response (CR), partial response (PR), or stable disease. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Aged ≥18 years. - Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 - Adequate organ and bone marrow function - Tumor type: Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy; Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy ### Exclusion criteria - Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor - Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases - Clinically significant concomitant pulmonary disease - A history of leptomeningeal carcinomatosis or carcinomatous meningitis - Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Sites - US-201New Haven, United StatesNot yet recruiting - US-202Sarasota, United StatesRecruiting - US-204Boston, United StatesNot yet recruiting - US-206Grand Rapids, United StatesRecruiting - US-205Nashville, United StatesRecruiting - US-203Houston, United StatesNot yet recruiting - US-207San Antonio, United StatesNot yet recruiting - AUS-101Liverpool, AustraliaNot yet recruiting - AUS-102Darlinghurst, AustraliaRecruiting - AUS-104Fitzroy, AustraliaNot yet recruiting - AUS-103Heidelberg, AustraliaNot yet recruiting - AUS-105Nedlands, AustraliaNot yet recruiting - CN-303Harbin, ChinaRecruiting - CN-301Shanghai, ChinaRecruiting - CN-302Hangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07197827) ## Related records ### Drugs (3) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) - [Tisagenlecleucel](https://trialight.com/data/asset/tisagenlecleucel-27723e3b-6eb9-4c5a-812c-e33edc463d77.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) ### Targets (3) - [CD19](https://trialight.com/data/target/cd19-2d6110ae-dc94-55e4-a832-9ebabdd3c941.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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