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.
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;
4. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4 hematologic toxicity, or ≥ Grade 3 non-hematologic toxicity) to prior standard therapy, or lack effective conventional treatment options;
5. (Phase Ib only) Patients requiring standard anti-tumor drug therapy per CSCO guidelines of advanced pancreatic cancer, non-small cell lung cancer, colorectal cancer, or other eligible solid tumors;
1. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction preventing adequate oral intake;
2. Use of any prescription medication intended to improve appetite or mitigate weight loss within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of the investigational product, including but not limited to anamorelin, megestrol acetate, cannabinoids, or medical marijuana;
3. Patients currently receiving tube feeding or parenteral nutrition support;
4. Treatment with any other investigational drug within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the study drug;
Jiangsu Nutai Biologics Co., Ltd
Lead sponsor
Jiangsu GQ Pharma Co., Ltd.
Collaborator