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A Trial of Y101D, a PD-L1/TGF-β Bispecific Antibody, in Patients With Metastatic or Locally Advanced Solid Tumors

NCT05028556 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-20

No results posted yet for this study

Summary

This is a phase 1, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of Y101D in patients with metastatic or locally advanced solid tumors.

Conditions

  • Metastatic or Locally Advanced Solid Tumors

Interventions

DRUG

Cohort 1 of Y101D

Y101D, 1mg/kg, Q2W, intravenous infusion

DRUG

Cohort 2 of Y101D

Y101D, 3mg/kg, Q2W, intravenous infusion

DRUG

Cohort 3 of Y101D

Y101D, 10mg/kg, Q2W, intravenous infusion

DRUG

Cohort 4 of Y101D

Y101D, 20mg/kg, Q2W, intravenous infusion

DRUG

Cohort 5 of Y101D

Y101D, 30mg/kg, Q2W, intravenous infusion

Sponsors & Collaborators

  • Wuhan YZY Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Cancer Prevention Center, Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-06
Primary Completion
2024-07-05
Completion
2024-09-09

Countries

  • China

Study Locations

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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 NCT05028556 on ClinicalTrials.gov