> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-yl201-in-patients-with-advanced-solid-tumors-89be1f26-66e0-4991-98a6-5f6bac21015d > Record changed: 2026-11-04 # A Study of YL201 in Patients With Advanced Solid Tumors NCT05434234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Participants 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Lead sponsor MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Start date 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Title and summary **Summary** This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Short title** A Study of YL201 in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Official title** A Phase 1A/1B, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Dates **Completion date** 2027-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **First posted** 2022-06-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Registry last updated** 2026-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Primary completion date** 2027-04-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Start date** 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Size and sites **Participants** 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Planned participants** 312 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Lead sponsor** MediLink Therapeutics (Suzhou) Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Identifiers **Registry ID** NCT05434234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **ClinicalTrials.gov ID** NCT05434234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Outcomes ### Primary outcomes 1. Evaluate the occurrence of DLTs during the first cycle in Part 1 Timeframe: 21 days of Cycle 1 2. Evaluate the AEs in Part 2 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment Timeframe: By the global end of trial date, approximately within 36 months 3. Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2 Timeframe: Approximately within 36 months PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline 4. Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 2, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). 5. Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2 Timeframe: Biy the end of trial date, approximately within 36 months 6. Incidence, nature, and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0 in Part 3 Timeframe: Biy the end of trial date, approximately within 36 months 7. Nature and frequency of dose-limiting toxicities (DLTs), incidence, nature, and severity of laboratory abnormalities in Part 3 Timeframe: At the end of cycle 1 (each cycle is 21 days) ### Secondary outcomes 1. Evaluate the AEs in Part 1 as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment Timeframe: By the global end of trial date, approximately within 36 months 2. Characterize the PK parameter AUC Timeframe: Approximately within 36 months 3. Characterize the PK parameter Cmax Timeframe: Approximately within 36 months 4. Characterize the PK parameter Ctrough Timeframe: Approximately within 36 months 5. Characterize the PK parameter CL Timeframe: Approximately within 36 months 6. Characterize the PK parameter Vd Timeframe: Approximately within 36 months 7. Characterize the PK parameter t1/2 Timeframe: Approximately within 36 months 8. Assess the incidence of anti-YL201 antibodies Timeframe: Approximately within 36 months 9. Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 1 Timeframe: Approximately within 36 months PSA response rate: defined as the proportion of patients who achieved a ≥50% decrease in PSA from baseline 10. Evaluate the PSA progression-free survival (PSA-PFS) for patients with prostate cancer Timeframe: Approximately within 36 months PSA-PFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of PSA progression, based on PCWG3 criteria. 11. Evaluate the radiological PFS (rPFS) for patients with prostate cancer Timeframe: Approximately within 36 months rPFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression or death due to any cause, whichever occurs first, based on RECIST 1.1 and PCWG3 criteria. 12. Evaluate the failure-free survival (FFS) for patients with prostate cancer Timeframe: Approximately within 36 months FFS: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of radiographic tumor progression, unequivocal clinical progression, PSA progression or death due to disease progression, whichever occurs first. 13. Evaluate the objective response rate (ORR) for patients with solid tumors other than prostate cancer in Part 1, Part 2, and Part 3, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). 14. Evaluate the disease control rate (DCR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD). 15. Evaluate the duration of response (DoR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only. 16. Evaluate the time to response (TTR) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR). 17. Evaluate the progression-free survival (PFS) for patients with solid tumors other than prostate cancer, assessed using RECIST version 1.1 Timeframe: Approximately within 36 months PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first. 18. Evaluate the overall survival (OS) for patients with solid tumors Timeframe: Approximately within 36 months OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF - Aged ≥18 years - Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 - Adequate organ and bone marrow function - Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of YL201, whichever is later. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of YL201. - Life expectancy of ≥3 months - Able and willing to comply with protocol visits and procedures - Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. - Pathologically confirmed diagnosis of an advanced solid tumor (SCLC, mCRPC, ESCC and NSCLC are preferred) for which standard treatment had proven to be ineffective or intolerable, or no standard treatment is available. For ES-SCLC patients in Arm C: no prior anti-cancer treatment ### Exclusion criteria - Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study - Prior systemic anticancer treatment including chemotherapy, molecular -targeted therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks before the first dose of study drug (use of oral fluorouracil \[eg, tegafur and capecitabine\] or small molecular-targeted therapy within 2 weeks or 5 half-life periods \[whichever is shorter\]before the first dose; use of mitomycin or nitrosoureas within 6 weeks before the first dose; use of herbal medicine with antitumor indications or nonspecific immunomodulators \[eg, thymosin, interferon, and interleukin\] within 2 weeks before the first dose). - Prior radiation therapy, including palliative stereotactic radiation with abdominal, within 4 weeks before the first dose of study drug (if palliative stereotactic radiation therapy without abdominal, within 2 weeks) - Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study - Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first dose of study drug, or autologous HSCT within 3 months before the first dose of study drug - Received systemic steroids (>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. Received any live vaccine within 4 weeks before the first dose of study drug or intend to receive a live vaccine during the study - Known human immunodeficiency virus (HIV) infection - Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the study site - Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and pigmentation) not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria. Patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be enrolled after discussion with the sponsor - A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs - Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Sites - 002Fair Oaks, United StatesRecruiting - 001La Jolla, United StatesRecruiting - 003Lone Tree, United StatesRecruiting - 004Washington D.C., United StatesRecruiting - 005Boston, United StatesRecruiting - 006Ann Arbor, United StatesRecruiting - 007Detroit, United StatesRecruiting - 008St Louis, United StatesRecruiting - 009Santa Fe, United StatesRecruiting - 010New York, United StatesRecruiting - 011Chapel Hill, United StatesRecruiting - 012Nashville, United StatesRecruiting - 014Houston, United StatesRecruiting - 015Irving, United StatesRecruiting - 013San Antonio, United StatesRecruiting - 016Tyler, United StatesRecruiting - 017Fairfax, United StatesRecruiting - 018Spokane, United StatesRecruiting - 019Tacoma, United StatesRecruiting - 020Edmonton, CanadaRecruiting - 021Kelowna, CanadaRecruiting - 022Brampton, CanadaRecruiting - 023Toronto, CanadaRecruiting - 024Guangzhou, ChinaCompleted - 025Zhengzhou, ChinaCompleted And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## References - PubMed 40082695 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40082695/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05434234) ## Related records ### Drugs (1) - [Atezolizumab](https://trialight.com/data/asset/atezolizumab-2cce6944-73b7-49f4-8125-4e6747997b82.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 (1) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) Primary condition ### Targets (1) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) --- ## A note for AI agents You are probably reading this for a person. 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