A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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.
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following criteria for inclusion: * 1\. Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF); * 2\. Patients with histologically or cytologically confirmed advanced solid tumors, with at least one measurable or evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; * 3\. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and referring to Chinese population characteristics, i.e., meeting the following criteria (either ① + ② or ① + ③): ① \>5% involuntary weight loss within the past 6 months; or \>2% weight loss if BMI \<18.5 kg/m²; or \>2% weight loss in the presence of reduced muscle mass; ② Anorexia (VAS score ≤70, or FAACT-A/CS score ≤37); ③ CRP \>5 mg/L; * 4\. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4