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

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.

NCT Number	NCT07231120
Lead Sponsor	Jiangsu Nutai Biologics Co., Ltd Collaborators: Jiangsu GQ Pharma Co., Ltd.
Conditions	Cachexia-Anorexia Syndrome, Solid Tumor Malignancies
Enrollment	54 participants
Start Date	2025-11-17
Primary Completion	2026-11-09 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-08