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;
Single group
SXRN Injection
DrugIntravenous 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
Phase Ia: MTD
To determine the Maximum Tolerated Dose (MTD) of SXRN Injection for the treatment of caner anorexia-cachexia.
Phase Ia&Ib: Incidence of Dose Limiting Toxicities (DLTs)
Phase Ib: RP2D
To determine the Recommended Phase II Dose (RP2D) of SXRN Injection.
Maximum serum concentration (Cmax) of SXRN Injection;
Time to Cmax (Tmax) of SXRN Injection
Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of SXRN Injection
Phase Ia&Ib: Average change in the severity of anorexia (based on the Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale-12 [FAACT-A/CS-12]) in the first cycle from baseline to each assessment timepoint.
Click on the lead sponsor to view all of their trials.
Jiangsu Nutai Biologics Co., Ltd
Lead sponsor
Jiangsu GQ Pharma Co., Ltd.
Collaborator
