drugset / Trial / NCT04359550

Study of ZKAB001 for Maintenance Therapy in Patients With High-grade Osteosarcoma After Adjuvant Chemotherapy

NCT04359550

Phase 3 Unknown 362 enrolled Lee's Pharmaceutical Limited
RandomizedParallel-groupTriple-blindTreatment

Summary

It is a randomized, double-blind, placebo-controlled, multicenter study with the sample size is 362. The patients with high-grade osteosarcoma who had previously received surgery and completed adjuvant chemotherapy will be randomly assigned to ZKAB001 group (trial group) or placebo group (control group) according to 1:1. The purpose is to evaluate the efficacy and safety of ZKAB001 in maintenance therapy after adjuvant chemotherapy in patients with high-grade osteosarcoma.

Timeline

Start
2020-06-01
Primary completion
2022-06-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Socazolimab Monoclonal antibody 10 mg/kg Other

Indications