A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors - Trial NCT06394414
Access comprehensive clinical trial information for NCT06394414 through Pure Global AI's free database. This Phase 1 trial is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. and is currently Not yet recruiting. The study focuses on Advanced Solid Tumors. Target enrollment is 162 participants.
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Study Focus
Sponsor & Location
MediLink Therapeutics (Suzhou) Co., Ltd.
Timeline & Enrollment
Phase 1
May 17, 2024
Apr 29, 2030
Primary Outcome
Evaluate the AEs in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors,To determine the MTD/RED of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors,To evaluate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR,To determine the RP2D of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR
Summary
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and
 Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based
 Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study
 will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part
 (Part 2).
 
 Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with
 serplulimab with or without platinum-based chemotherapy in selected subjects with advanced
 solid tumors.
 
 Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without
 platinum-based chemotherapy in selected subjects with advanced solid tumors.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06394414
Non-Device Trial