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NCT06384352 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumors, sponsored by MediLink Therapeutics (Suzhou) Co..

Recruiting
Registry status
Phase 1
Development phase
155
Enrollment target
20
Study locations

NCT06384352: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by MediLink Therapeutics (Suzhou) Co..

NCT06384352 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by MediLink Therapeutics (Suzhou) Co.. The registered enrollment target is 155 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06384352, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by MediLink Therapeutics (Suzhou) Co..

RECRUITING
Registry status
Phase 1
Development phase
155 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

AE's

Conditions Studied

Interventions

  • DRUG YL211

Study Locations (20)

Texas

  • The University of Texas - MD Anderson Cancer Center - Houston
  • NEXT Oncology - Houston - Houston
  • NEXT Oncology - Dallas - Irving
  • NEXT San Antonio - San Antonio

Other

  • Monash Health - Melbourne
  • The Ottawa Hospital - General Campus - Ottawa
  • West China Hospital, Sichuan University - Chengdu

Colorado

  • University of Colorado Hospital - Anschutz Cancer Pavilion - Aurora
  • Sarah Cannon Research Institute (SCRI) at HealthONE - Denver

Florida

  • Sarah Cannon Research Institute at Florida Cancer Specialists - Orlando
  • Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office - Sarasota

Zhejiang

  • The First Affiliated Hospital - Zhejiang University School of Medicine - Hangzhou
  • Wenzhou Medical University - The First Affiliated Hospital - Wenzhou

Connecticut

  • Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven - North Haven

Nevada

  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley - Las Vegas

Ohio

  • University of Cincinnati Vontz Center for Molecular Studies - Cincinnati

Trial Details

FieldValue
Enrollment Target 155 participants
Start Date 2024-05-01
Est. Completion 2029-04-07
Phase Phase 1

What NCT06384352 shows while recruiting

NCT06384352 is an interventional study that assigns participants to a tested intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (22% lower).

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which YL211 is the first listed.

NCT06384352 names 20 study sites across 12 states, led by Texas, Other, Colorado.

Frequently Asked Questions

What is clinical trial NCT06384352 about?

NCT06384352 is a clinical study titled "A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy 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 R...

What is the current status of trial NCT06384352?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 155 participants. The study started on 2024-05-01. Estimated completion is 2029-04-07.

What conditions does trial NCT06384352 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT06384352?

The interventions under investigation include: YL211 (DRUG).

Who is sponsoring clinical trial NCT06384352?

This trial is sponsored by MediLink Therapeutics (Suzhou) Co., which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06384352 being conducted?

This trial has 20 study locations across Colorado, Connecticut, Florida, Nevada, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06384352's enrollment target sits among peer trials

155 56th of 144 higher than 88 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06384352, the US trial registry maintained by the National Library of Medicine. NCT06384352 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.