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NCT06394414Not yet recruiting

A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

A Phase 1, Multicenter, Open-label Study 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
MediLink Therapeutics (Suzhou) Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Advanced Solid Tumors
Drug/Device/Intervention
YL201
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Location
Chongqing,Guangzhou,Nanning,Zhengzhou,Zhengzhou,Wuhan,Changsha,Nanchang,Nanchang,Jinan,Chengdu,Hangzhou,Taizhou, China
Timeline & enrollment
Phase
Phase 1
Start date
May 17, 2024
End date
Apr 29, 2030
Enrollment
162 participants
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
Malignant neoplasm: PrepuceCarcinoma in situ, unspecifiedMalignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm: Orbit
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06394414
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.