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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 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.

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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.

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 the Registry Record Tells You About NCT06384352

The ClinicalTrials.gov registry entry for NCT06384352 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 155 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (22% lower). The listed sponsor is MediLink Therapeutics (Suzhou) Co., which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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