drugset / Trial / NCT05116709

Assessment of Safety and Preliminary Clinical Efficacy with BAT6005 in Advanced Malignant Solid Tumors

NCT05116709 ↗

Phase 1 Completed 28 enrolled Bio-Thera Solutions
NaSequentialOpen-labelTreatment

Summary

This research design for center, increasing openness, dose and dose extension phase I clinical trials, research the main evaluation BAT6005 injection single drug in patients with advanced malignant solid tumors in the safety, tolerability and PK characteristics, to explore the maximum tolerated dose and preliminary antitumor efficacy, provide the basis for subsequent clinical trials recommended dose. Part I: single drug dose escalation study. Part TWO: dose extension study.

Timeline

Start
2021-11-12
Primary completion
2024-01-10
Completion
2024-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT6005 Monoclonal antibody 10 mg —
Subject BAT6005 Monoclonal antibody 30 mg —
Subject BAT6005 Monoclonal antibody 100 mg —
Subject BAT6005 Monoclonal antibody 300 mg —
Subject BAT6005 Monoclonal antibody 600 mg —
Subject BAT6005 Monoclonal antibody 900 mg —

Indications

No indication recorded.