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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Metastatic or Locally Advanced Solid Tumors
  • Neoplasms

NCT number NCT05028556
Study type Interventional
Source Wuhan YZY Biopharma Co., Ltd.
Contact Shaoyi Huang, PhD
Phone 86-27-82668988
Email [email protected]
Status Recruiting
Phase Phase 1
Start date August 6, 2021
Completion date August 6, 2023

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