Actively Recruiting
A Study of JMT203 in Patients With Cancer Cachexia
Led by Shanghai JMT-Bio Inc. · Updated on 2025-03-11
130
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multicenter Phase I clinical study aimed at evaluating the safety/tolerability, pharmacokinetics, and effectiveness of JMT203 in patients with cancer cachexia.
CONDITIONS
Official Title
A Study of JMT203 in Patients With Cancer Cachexia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Willingness to voluntarily participate and sign informed consent
- Confirmed malignant solid tumor with ongoing or completed anti-tumor treatment and no significant tumor progression within 28 days before first drug dose
- For Phase Ia: No expected need to change anti-tumor treatment during first 21 days of study
- For Phase Ib: Patients with non-small cell lung, pancreatic, or colorectal cancer
- Diagnosed with cancer cachexia by 2011 International Consensus criteria, showing specific weight loss or BMI criteria within 6 months
- For Phase Ib: Serum GDF-15 levels ≥1300 pg/ml within 28 days before first drug dose
- Adequate organ function based on laboratory tests including blood counts, kidney, liver, and coagulation parameters
- ECOG Performance Status score of 2 or less
- Estimated survival of at least 4 months
- Fertile patients must use contraception from consent until 6 months after last drug dose; females of childbearing age must have negative pregnancy test within 7 days before first drug dose
You will not qualify if you...
- Reversible causes leading to decreased food intake
- Dysphagia or poor digestion/absorption conditions such as gastrointestinal obstruction or inflammatory bowel disease
- Cachexia caused by other clear causes like severe COPD, uncontrolled thyroid disease, organ failure, or AIDS
- Receiving tube feeding or parenteral nutrition during screening
- Use of prescription appetite enhancers or weight loss treatments within 28 days before first drug dose
- Use of systemic glucocorticoids or immunosuppressive therapies within 28 days before first drug dose, except pretreatment for antitumor therapy
- Body mass index over 30 kg/m²
- Major surgery within 4 weeks before first drug dose and not recovered or planned during study
- Participation in other clinical studies within 4 weeks before first drug dose
- Severe infections requiring intravenous antibiotics, antivirals, or antifungals during screening
- Difficult-to-control serous cavity effusions within 14 days before first drug dose
- Second primary active malignancy within 2 years before first drug dose, except certain treated local tumors
- Active central nervous system metastases unless controlled within 28 days before investigational product use
- Severe cardiovascular disease history including serious arrhythmias, recent major cardiovascular events, or low heart function
- Severe immune deficiency or history of organ transplant
- Recent or current depression or suicidal tendencies
- Known allergy to JMT203 or its components
- History of severe allergic reactions or uncontrollable allergic asthma
- Investigator judgment deeming patient unsuitable 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
Sir run run shaw Hospital
Zhejiang, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group Officer
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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