Actively Recruiting
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
Led by Jiangsu Nutai Biologics Co., Ltd · Updated on 2025-12-08
54
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
J
Jiangsu Nutai Biologics Co., Ltd
Lead Sponsor
J
Jiangsu GQ Pharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years at the time of consent
- Diagnosed with advanced solid tumors confirmed by histology or cytology, with at least one measurable or evaluable lesion
- Diagnosed with cancer anorexia-cachexia based on 2025 guidelines, including significant involuntary weight loss and anorexia or elevated CRP levels
- For Phase Ia: patients who have failed or cannot tolerate prior standard therapies or lack effective treatment options
- For Phase Ib: patients requiring standard anti-tumor therapy for cancers like pancreatic, non-small cell lung, or colorectal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Laboratory and organ function tests within specified limits prior to first dose
- Ability to understand and voluntarily sign informed consent and comply with study procedures
You will not qualify if you...
- Reversible causes of reduced food intake such as mechanical obstruction
- Use of medications to improve appetite or prevent weight loss within 28 days prior to study drug
- Currently receiving tube feeding or parenteral nutrition
- Treatment with other investigational drugs within 4 weeks prior to study drug
- Cachexia caused by other diseases like severe COPD or AIDS
- Hormonal therapy that may affect cachexia assessment
- Major surgery or interventional procedures within 4 weeks prior to study drug
- Unresolved toxicities from previous antitumor therapies above grade 1
- Uncontrolled fluid accumulation such as pleural effusion or ascites
- Central nervous system metastases requiring intervention
- History of other cancers unless treated with no recurrence within 5 years
- History of immunodeficiency or organ transplantation
- Recent pulmonary inflammation requiring steroids
- Severe cardiovascular or cerebrovascular diseases
- Uncontrolled hypertension
- Active chronic hepatitis B or C, or HIV infection
- Active infection requiring treatment within 2 weeks prior to first dose
- History of active tuberculosis within 1 year
- Other uncontrolled or significant comorbid diseases
- Known allergy to SXRN Injection or related substances
- For premenopausal women: positive pregnancy test, breastfeeding, or unwillingness to use contraception
- Any other condition deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
N
Ning Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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