NCT05193214

A Phase II Study for 609A in the Treatment of Advanced Undifferentiated Pleomorphic Sarcoma

An Open Label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (609A) in Patients With Unresectable or Advanced Undifferentiated Pleomorphic Sarcoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy and safety of recombinant anti-PD-1 humanized monoclonal antibody injection (609A) in patients with unresectable or advanced undifferentiated pleomorphic sarcoma

Detailed description

This is a multi-center, open label, phase II clinical study. The safety and effectiveness of 609A in the treatment of unresectable or advanced undifferentiated pleomorphic sarcoma are mainly evaluated by ORR (based on the results of CT/MRI examination of subjects during treatment).

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Recombinant anti-PD-1 humanized monoclonal antibody injection	Each subject received 609A 200 mg intravenous infusion, once every 3 weeks (Q3W), until disease progression, intolerable toxicity, death, informed withdrawal, early withdrawal from the study, loss to follow-up, or the end of the study, whichever occurs first Whichever prevails.

Timeline

• Start date: 2022-01-25
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2022-01-14
• Last updated: 2022-01-14

Locations

1 site across 1 country: China