drugset / Trial / NCT04458389

A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas

NCT04458389 ↗

Phase 1/2 Unknown 268 enrolled Tayu Huaxia Biotech Medical Group Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

A multicenter, open-label, dose-escalation and dose-expansion phase 1/2 study, to evaluate TY101 safety, tolerability, pharmacokinetic characteristics, effectiveness and immunogenicity in patients with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas. The study includes two parts: dose escalation and expansion cohort to evaluate the tolerability and efficacy.

Timeline

Start
2020-12-07
Primary completion
2024-06-30
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TY101 Monoclonal antibody 0.3 mg/kg Intravenous
Subject TY101 Monoclonal antibody 1 mg/kg Intravenous
Subject TY101 Monoclonal antibody 3 mg/kg Intravenous
Subject TY101 Monoclonal antibody 10 mg/kg Intravenous
Subject TY101 Monoclonal antibody 200 mg Intravenous

Indications