Phase I Study of SXRN Injection for Safety and Preliminary Effectiveness in Adults With Cancer Cachexia and Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and early effects of SXRN Injection in cancer patients suffering from anorexia-cachexia. This clinical trial has two phases Phase Ia is a single-arm, open-label study with dose escalation, and Phase Ib extends the study by combining SXRN Injection with standard anti-tumor therapies in cancers like pancreatic cancer, non-small cell lung cancer, and colon cancer. The study is sponsored by Jiangsu Nutai Biologics Co., Ltd. and Jiangsu GQ Co., Ltd. In Phase Ia, participants receive one of 3 to 4 escalating doses of SXRN Injection 4 mg, 6 mg, 8 mg, or another dose, given intravenously once daily for 5 days followed by a 2-day break, forming a 3-week treatment cycle. Phase Ib includes two dose levels 6 mg and 8 mg combined with standard anti-tumor treatment. Participants are enrolled sequentially by dose levels. The study plans to enroll 12-24 patients in Phase Ia and 20-30 in Phase Ib and is conducted at 1-2 centers nationwide. Participants will undergo various assessments including blood tests, physical function tests, weight and body composition measurements, questionnaires on appetite and quality of life, and tumor evaluations. Researchers will monitor side effects, drug levels in the body, and treatment responses up to 12 months or longer. The primary outcomes include maximum tolerated dose, dose-limiting toxicities, and recommended phase 2 dose. Secondary measures involve changes in appetite, physical function, body weight, survival, and tumor response. Participants will be followed closely during and after treatment.

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