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NCT06384352Recruiting

A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
MediLink Therapeutics (Suzhou) Co., Ltd.Phase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Advanced Solid Tumors
Drug/Device/Intervention
YL211
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Location
Houston,San Antonio, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2024
End date
Apr 07, 2029
Enrollment
155 participants
Primary outcome

To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0,To evaluate nature and frequency of DLTs in part 1.,ORR assessed using RECIST version 1.1,To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors

Summary

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with
 advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1,
 the safety and tolerability of YL211 in patients with selected advanced solid tumors will be
 evaluated and the MTD and RED will be determined.
 
 Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211
 in patients with selected adcance tumor to select the RED(s) of YL211.
 
 Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy
 of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be
 administered intravenously (IV) until criteria of treatment discontinuation are met.

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
NCT06384352
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06384352 through Pure Global AI's free database. This Phase 1 trial is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd. and is currently Recruiting. The study focuses on Advanced Solid Tumors. Target enrollment is 155 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.