NCT07231120

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Jiangsu Nutai Biologics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.

Detailed description

This study is collaboratively sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd.. Nutai serves as the Responsible Party for this registration.

Conditions

• Cachexia-Anorexia Syndrome
• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	SXRN Injection	Intravenous infusion, qd for 5 consecutive days, followed by a 2-day break; every 3 weeks (21days) makes a treatment cycle. Ⅰa phase：conventional "3+3" design for dose escalation； Ⅰb phase：standard anti-tumor therapy combined with SXRN Injection

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-11-09
• Completion: 2026-12-30
• First posted: 2025-11-17
• Last updated: 2025-12-08

Locations

1 site across 1 country: China