drugset / Trial / NCT04727164

Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab

NCT04727164

Phase 1 Unknown 61 enrolled Harbour BioMed (Guangzhou) Co. Ltd.
NaSingle-groupOpen-labelTreatment

Summary

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

Timeline

Start
2021-02-28
Primary completion
2023-11
Completion
2023-11

Drugs

EvaluationDrugModalityDoseRoute
Subject PORUSTOBART Monoclonal antibody 0.03 mg/kg
Subject PORUSTOBART Monoclonal antibody 0.1 mg/kg
Subject PORUSTOBART Monoclonal antibody 0.3 mg/kg
Subject Toripalimab Monoclonal antibody 240 mg

Indications