NCT06384352

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YL211	Patients will be treated with YL211 intravenous (IV) infusion.

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-04-07
• Completion: 2029-04-07
• First posted: 2024-04-25
• Last updated: 2026-01-02

Locations

21 sites across 4 countries: United States, Australia, Canada, China

Regulatory

• FDA-regulated drug study