{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"INT-101-01","nct_id":"NCT05434234","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=int-101-01-nct05434234. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"All participants enrolled in the dose escalation part","label":"Dose escalation","type":"EXPERIMENTAL"},{"description":"All participants enrolled in the dose expansion part","label":"Dose expansion","type":"EXPERIMENTAL"},{"description":null,"label":"Dose Selection","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-10-06","type":"ESTIMATED"},"conditions":["Advanced Solid Tumor"],"enrollment":{"count":312,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"YL201","otherNames":[],"type":"DRUG"},{"name":"YL201","otherNames":[],"type":"DRUG"},{"name":"YL201 and atezolizumab","otherNames":[],"type":"DRUG"}],"last_update":"2026-06-22","lead_sponsor":"MediLink Therapeutics (Suzhou) Co., Ltd.","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","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-04-06","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Evaluate the occurrence of DLTs during the first cycle in Part 1","timeFrame":"21 days of Cycle 1"},{"measure":"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"},{"measure":"Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer in Part 2","timeFrame":"Approximately within 36 months"},{"measure":"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"},{"measure":"Laboratory abnormalities as characterized by type, frequency, severity, and timing in Part 2","timeFrame":"Biy the end of trial date, approximately within 36 months"},{"measure":"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"},{"measure":"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)"}],"references":[{"citation":"Ma Y, Yang Y, Huang Y, Fang W, Xue J, Meng X, Fan Y, Fu S, Wu L, Zheng Y, Liu J, Liu Z, Zhuang W, Rosen S, Qu S, Li B, Li M, Zhao Y, Yang S, Ji Y, Sommerhalder D, Luo S, Yang K, Li J, Lv D, Zhang P, Zhao Y, Hong S, Zhang Y, Zhao S, Chin S, Zhang X, Lian W, Cai J, Xue T, Zhang L, Zhao H. A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. Nat Med. 2025 Jun;31(6):1949-1957. doi: 10.1038/s41591-025-03600-2. Epub 2025 Mar 13.","pmid":"40082695","type":"DERIVED"}],"start_date":{"date":"2022-05-25","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of YL201 in Patients With Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT05434234"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/int-101-01-nct05434234"}