A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
- Disease/Condition
- Advanced Solid Tumors
- Drug/Device/Intervention
- YL211
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Location
- Houston,San Antonio, United States of America
- Phase
- Phase 1
- Start date
- May 01, 2024
- End date
- Apr 07, 2029
- Enrollment
- 155 participants
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
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06384352
- Type
- Non-Device Trial
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.