NCT05028556

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

A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of Y101D, a Recombinant Anti-PD-L1 and TGF-β Bispecific Antibody for Injection, in Patients With Metastatic or Locally Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Wuhan YZY Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will consist of two parts: dose escalation part and cohort expansion part. In dose escalation part, up to 5 dose-escalation cohorts will be sequentially enrolled in this study. The five dose levels are 1, 3, 10, 20 and 30 mg/kg. DLTs will be evaluated during the first treatment cycle, which is 28 days. The study consists of a 4-week screening period, a 4-week core treatment period for DLT evaluation, a treatment extension period, a safety follow-up visit for approximately 30 days following the last dose of Y101D, and survival follow-ups every 3 months thereafter. In cohort expansion part, To further characterize safety and efficacy of Y101D, cohort expansion will be allowed in the following two circumstances: MTD cohort expansion if the MTD could be identified; Benefited dose cohort if it could be determined by Investigator.

Conditions

• Metastatic or Locally Advanced Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-08-06
• Primary completion: 2024-07-05
• Completion: 2024-09-09
• First posted: 2021-08-31
• Last updated: 2025-07-20

Locations

3 sites across 1 country: China