A Study of JMT203 in Patients With Cancer Cachexia (NCT06868849) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of JMT203 in Patients With Cancer Cachexia
China307 participantsStarted 2024-05-15
Plain-language summary
A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old;
. Voluntarily participate in the study and sign the informed consent form;
. Age ≥ 18 years old;
. Voluntarily participate in the study and sign the informed consent form;
. Malignant solid tumors confirmed histologically or cytologically, with ongoing or completed anti-tumor treatment, and no significant tumor progression within 28 days prior to the first drug administration，and the investigator estimates that the participant will not require a switch to another anticancer therapy due to disease progression during the first treatment cycle (21 days). For the Phase II portion:
. Diagnosed with cancer cachexia according to the criteria of the 2011 International Consensus on Cancer Cachexia: Definition and Classification, combined with characteristics of the Chinese population, i.e., presenting with one of the following within 6 months (previous weight data must be supported by written documentation approved by the sponsor): involuntary weight loss \>5%, or weight loss \>2% when Body Mass Index （BMI） \<18.5 kg/m²;
. Adequate organ function, meeting relevant laboratory test standards （without transfusion or hematopoietic growth factor support within 14 days prior to testing）:
. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: ≤1;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Timeframe: Up to 90 days after the last dose of JMT203
2
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
Timeframe: Up to 21 days after the first dose of JMT203
3
Phase Ia: MTD (if applicable).
Timeframe: Up to 90 days post last dose
4
Phase Ia: RDE.
Timeframe: Up to 90 days post last dose
5
Phase Ib: Average change in body weight from baseline at each assessment timepoint within 12 weeks.
. Presence of reversible causes leading to decreased food intake;
. Patients with dysphagia or poor food digestion and absorption, including gastrointestinal obstruction, active inflammatory bowel disease, or short bowel syndrome;
. Patients with cachexia caused by clearly identified other causes, such as severe chronic obstructive pulmonary disease, uncontrolled thyroid disease, vital organ failure, or Acquired Immune Deficiency Syndrome （AIDS）;
. Patients receiving tube feeding or parenteral nutrition therapy during the screening period;
. Patients who have taken any prescription medications for appetite enhancement or improve weight loss within 28 days or 5 half-lives (whichever is shorter) before the first study drug administration, including but not limited to anamorelin, medroxyprogesterone acetate, dronabinol, medical marijuana, etc.;
. Initiation of systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of other similar drugs) or other immunosuppressive therapies within 28 days before the first study drug administration, excluding pretreatment for antitumor therapy;
. Patients with a BMI exceeding 30 kg/m²;
. Patients who have undergone major surgery within 4 weeks before the first study drug administration and have not recovered, or are expected to undergo major surgery during the study;