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Tests treatment safety and results for Cachexia-Anorexia Syndrome
Official title A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
ClinicalTrials.gov ID: NCT07231120
What this study is testing
What is SXRN Injection?
SXRN Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cachexia-anorexia syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 3\. Diagnosed of cancer anorexia-cachexia based on the 2025 Guidelines for the Diagnosis and Treatment of Cancer Anorexia-Cachexia Syndrome and...
- 4\. (Phase Ia only) Cancer patients who have failed or are intolerant (experienced drug-related ≥ Grade 4 hematologic toxicity, or ≥ Grade 3...
You likely can't join if
- Participants meeting any of the following criteria shall be excluded from the study:
- 1\. Reversible causes of reduced food intake as determined by the investigator, which may include but are not limited to mechanical obstruction...
- 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...
- 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;
- 5\. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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;
- 6\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
- 7\. Life expectancy ≥12 weeks.
- 8\. Laboratory test results and organ function assessed within 7 days prior to the first dose must meet the following criteria:
- Blood routine: 1)Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L;2)Platlets (PLT) Count≥75×10\^9/L; 3)Hemoglobins (Hb) ≥80 g/L. Note: the criteria above shall still be maintained within 14 days before the initial infusion...
- Blood biochemistry: 1)Total bilirubin (TBIL) ≤3.0 × upper limit of normal (ULN); 2)Serum creatinine (SCr) ≤1.5 × ULN or creatinine clearance (CrCl) by Cockroft Gault formula ≥30 mL/min; 3)Aspartate Amino Transferase...
- Urine routines: Urine protein ≤2+ (if \>2+, 24-hour urine protein quantification must be performed, and total protein ≤1 g is required for eligibility).
- Blood coagulation: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Note: for people receiving precautious anti-coagulation treatment, the investigator...
- Ultrasonic cardiogram: Left Ventricular Ejection Fraction (LVEF) ≥50%.
- 9.The participant must be able to understand and voluntarily sign the written Informed Consent Form (ICF); and must be willing and able to comply with all study procedures and follow-up examinations.
What rules you out
- Participants meeting any of the following criteria shall be excluded from the study:
- 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...
- 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;
- 5\. Patients with cachexia clearly attributable to other underlying conditions, such as severe chronic obstructive pulmonary disease (COPD), AIDS, etc.;
- 6\. Hormonal therapy judged by the investigator as potentially to improve the assessment of cachexia-related outcomes.
- 7\. Patients who have undergone major surgery or treatment procedures within 4 weeks prior to the first dose, or who are scheduled to undergo such procedures during the trial (excluding tumor biopsy, puncture, etc.);
- 8\. Patients with toxicities from previous antitumor therapies that have not yet recovered to ≤ Grade 1 or baseline levels (except for toxicities judged by the investigator as to pose no safety risk, such as alopecia...
- 9\. Clinically uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion), meeting any of the following criteria: moderate or larger volume, received local treatment...
- 10.Patients with central nervous system metastases requiring intervention;
- 11.History of other malignancies, except for those who have undergone curative treatment with no recurrence within 5 years (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin, etc.);
- 12.History of immunodeficiency, including acquired or congenital immunodeficiency diseases, organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation;
- 13.(Non-infectious) pulmonary inflammation/interstitial lung disease requiring steroid therapy within 4 weeks prior to the first infusion;
- 14.History of severe cardiovascular or cerebrovascular diseases, including but not limited to:
- Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;
- Cardiac dysfunction classified as Class III-IV per the New York Heart Association (NYHA) criteria;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular/cerebrovascular events within 6 months prior to the first dose;
- 15.Hypertension uncontrolled by a stable regimen of antihypertensive medication (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg);
- 16.Active chronic hepatitis B (e.g., HBsAg positive or HBcAb positive with HBV DNA above the lower limit of detection), active hepatitis C (e.g., HCV antibody positive with HCV RNA above the lower limit of detection)...
- 17.Active infection requiring systemic therapy within 2 weeks prior to the first dose;
- 18.History of active tuberculosis infection within 1 year prior to the first dose;
- 19.Any other uncontrolled or significant comorbid disease(s), either currently or historically, that by the investigator's judgment may interfere with trial participation or evaluation;
- 20.Known allergy or contraindication to the investigational product (SXRN injection) or its drug substance process-related impurities (e.g., spectinomycin);
- 21.For premenopausal female participants (postmenopausal females must be amenorrheic for at least 12 months to be considered of non-childbearing potential): serum pregnancy test as positive, or participants of...
- 22\. Any other condition that considered by the investigator as to render the patient unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.