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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 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-11-30

No results posted yet for this study

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

Conditions

  • Sarcoma, Soft Tissue

Interventions

DRUG

609A

609A 200mg,IV, Day 1of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 3 weeks a treatment cycle.

DRUG

doxorubicin hydrochloride

60mg/m2 or 75mg/m2, IV, Day1of the1-6th treatment cycles only. Every 3 weeks a treatment cycle.

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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 NCT05138146 on ClinicalTrials.gov