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

NCT06384352 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-01-02

No results posted yet for this 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

Interventions

DRUG

YL211

Patients will be treated with YL211 intravenous (IV) infusion.

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • MediLink Therapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2027-04-07
Completion
2029-04-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06384352 on ClinicalTrials.gov