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

A Single Arm，Open Label，Multi-centers，Phase 2 Study, Aimed to Evaluate the Efficacy and Safety 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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a single-arm, open, multi-center phase 2 study aimed at evaluating the efficacy and safety of 609A combined with doxorubicin hydrochloride in patients with metastatic/unresectable non-specified soft tissue sarcoma. This study is divided into the first part (safety introduction period) and the second part (phase II). Part 1: Security lead-in period The safety lead-in period adopts a single-arm, open design to evaluate the safety, tolerability and preliminary effectiveness of 609A combined with doxorubicin hydrochloride. Which aimed to explore the Recommended phase II dose (RP2D). Part 2: Phase 2 This part adopts a single-arm, open, Simon two-stage design to further evaluate the anti-tumor efficacy and safety of 609A combined with doxorubicin hydrochloride.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-30
• Primary completion: 2023-11-30
• Completion: 2024-12-30
• First posted: 2021-11-30
• Last updated: 2021-11-30

Locations

1 site across 1 country: China