A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia
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;
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;
Parallel
JMT203 Injection
DrugDrug：JMT203 Injection * Anti-GFRAL monoclonal antibody * Will be injected subcutaneously once per cycle (3 weeks, on Day 1) for 12 weeks, or will be injected subcutaneously once per cycle (3 weeks, on Day 1).
JMT203 Injection
DrugDrug：JMT203 Injection * Anti-GFRAL monoclonal antibody * Will be injected subcutaneously once per cycle (3 weeks, on Day 1) for 12 weeks, or will be injected subcutaneously once per cycle (3 weeks, on Day 1).
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Phase Ia: Incidence of dose-limiting toxicity (DLT) events
Phase Ia: MTD (if applicable).
Phase Ia: RDE.
Phase Ia: Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of JMT203
Phase Ia: Maximum measured plasma concentration (Cmax) of JMT203
Phase Ia: Time when Cmax occurred (Tmax) of JMT203
Phase Ia: Incidence of anti-drug antibodies (ADA).
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