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

NCT05193214 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-01-14

No results posted yet for this study

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

Conditions

  • Sarcoma, Soft Tissue

Interventions

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.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaohui Niu, Master · Beijing Jishuitan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-25
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05193214 on ClinicalTrials.gov