drugset
drugset / Trial / NCT05138146

A Phase 2 Clinical Study of Evaluation of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) Combined With Doxorubicin Hydrochloride in the Treatment of Metastatic/Unresectable Non-specific Soft Tissue Sarcoma

NCT05138146 ↗

Phase 2 Unknown 70 enrolled Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, open label, phase 2 study aimed to evaluate the efficacy and safety of the combination recombinant anti-PD-1 humanized monoclonal antibody injection (609A) and doxorubicin hydrochloride in the treatment of metastatic/unresectable non-specific soft tissue sarcoma

Timeline

Start
2021-12-30
Primary completion
2023-11-30
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 609A Monoclonal antibody 200 mg Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 75 mg/m2 Intravenous

Indications

soft tissue sarcoma