Actively Recruiting
A Phase Ia/II Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia
Led by Shanghai JMT-Bio Inc. · Updated on 2026-05-22
307
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of JMT203 in patients with cancer cachexia, a condition characterized by severe weight loss in people with cancer. This study includes two parts: Phase Ia, focusing on dose escalation and expansion to find safe and effective doses, and Phase II, a randomized, double-blind, placebo-controlled trial involving patients with colorectal cancer cachexia, pancreatic cancer cachexia, or cachexia from other solid tumors. The study aims to determine the recommended dose for future studies and assess preliminary treatment effects over 12 weeks. During Phase Ia, JMT203 will be tested in increasing doses using an accelerated titration design with a 3+3 dose escalation scheme. Dose expansion will select 1 to 3 potentially effective doses based on safety and pharmacokinetic data. In Phase II, participants will be randomly assigned to receive either JMT203 at 50 mg or 150 mg, or a placebo, administered as subcutaneous injections every three weeks for 12 weeks. An open-label extension phase may continue treatment at 150 mg or the recommended Phase 3 dose for up to 51 weeks. Participants will undergo regular assessments including monitoring adverse events, dose-limiting toxicities, and changes in body weight and muscle mass. Imaging by computed tomography and questionnaires about anorexia severity will be used to evaluate effects. Pharmacokinetic measurements and antibody responses will be tracked up to 90 days after dosing. The study also monitors survival and progression-free survival up to three years. Participants can expect visits for treatment administration, safety checks, and evaluation of their cancer cachexia symptoms throughout the study period.
CONDITIONS
Brief 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
- Voluntarily agree to participate and sign the informed consent form
- Have a confirmed diagnosis of malignant solid tumors with ongoing or completed anti-tumor treatment and no major tumor progression within 28 days before first drug dose
- For Phase II: Specific treatment status depending on cancer type, including receiving or about to start standard anticancer therapy with limited prior therapy cycles
- Diagnosed with cancer cachexia based on international consensus criteria, including recent involuntary weight loss or low BMI
- Have adequate organ function without recent transfusion or growth factor support
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2 or less
- Estimated survival of 4 months or more
- Use contraceptive measures if fertile and have a negative pregnancy test before first drug dose if female of childbearing age
You will not qualify if you...
- Have reversible causes for decreased food intake
- Have swallowing or digestion problems such as gastrointestinal obstruction or inflammatory bowel disease
- Cachexia caused by other conditions like severe COPD, uncontrolled thyroid disease, organ failure, or AIDS
- Receiving tube feeding or parenteral nutrition during screening
- Taken appetite-enhancing medications recently before study drug administration
- Started systemic glucocorticoids or immunosuppressive therapy recently, except pretreatment for antitumor therapy
- Body Mass Index (BMI) over 30 kg/m²
- Had major surgery within 4 weeks before first study drug dose and not recovered
- Received other clinical study drugs within 4 weeks before first dose
- Severe infections requiring intravenous treatment during screening
- Moderate to large fluid buildup in chest, abdomen, or heart areas before first dose
- Second primary active cancer within 2 years, except certain treated local tumors
- Active brain or central nervous system metastases, unless controlled
- History of severe heart disease or recent serious cardiovascular events
- Severe immune deficiency or history of organ transplant
- Recent or current depression or suicidal thoughts
- Known allergy to JMT203 or its components
- History of severe allergic reactions or uncontrolled asthma
- Other investigator-assessed reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days after the last dose
Participants undergo dose escalation and dose expansion of JMT203 to assess safety, tolerability, and determine the recommended dose for expansion.
Multiple visits during dose escalation and expansion phase
Duration - 12 weeks
Participants receive JMT203 injections or placebo subcutaneously once every 3 weeks over a 12-week treatment period to evaluate preliminary efficacy and safety.
Injections every 3 weeks with regular visits during treatment
Duration - Up to 90 days after the last dose, with some assessments up to 3 years
Safety and efficacy monitoring continue after treatment ends, including assessment of adverse events and long-term outcomes.
Follow-up visits for up to 3 years depending on outcomes assessed
Trial Site Locations
Total: 1 location
1
Sir run run shaw Hospital
Zhejiang, China
Actively Recruiting
Research Team
C
Clinical Trials Information Group Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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