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

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Trial Identification

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

Official Title: 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

Study ID: NCT05028556

Conditions

Metastatic or Locally Advanced Solid Tumors

Interventions

Study Description

Brief 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.