An Open-label, Multi-center, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia
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.
• 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:
‣ Dose escalation and expansion phase (Phase Ia): The investigator predicts that there will be no need to change the anti-tumor treatment regimen due to disease progression within the first dosing cycle (21 days) of this study;
⁃ Cohort expansion study phase (Phase Ib): Cohorts A/B/C will enroll patients with non-small cell lung cancer, pancreatic cancer, and colorectal cancer, respectively;
• 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;
• Serum Growth Differentiation Factor 15 （GDF-15） levels ≥1300 pg/ml within 28 days prior to the first study drug administration (applicable to the cohort expansion phase only);
• Adequate organ function, meeting relevant laboratory test standards:
• Item Laboratory Test Value Blood Absolute Neutrophil Count ≥1.0×10\^9/L Platelet Count ≥75×10\^9/L Hemoglobin ≥80 g/L Kidney Serum Creatinine ≤1.5×ULN (if \>1.5×ULN, creatinine clearance calculated by the Cockcroft formula must≥30 ml/min) Liver Total Bilirubin ≤1.5×ULN (For patients with liver metastasis, liver cancer, or bile duct obstruction: may be relaxed to ≤3×ULN) AST and ALT ≤3×ULN or ≤5×ULN for patients with liver metastasis Coagulation APTT ≤1.5×ULN INR ≤1.5×ULN Note: ULN = Upper Limit of Normal; if laboratory tests do not meet the criteria, the investigator will determine eligibility based on the patient's overall condition.
• 7\. Eastern Cooperative Oncology Group Performance Status （ECOG PS）score: ≤2;
• Estimated survival ≥4 months;
• Fertile eligible patients must use adequate contraceptive measures from the time of signing the informed consent form until 6 months after the last drug administration; female patients of childbearing age must have a negative serum pregnancy test within 7 days before the first drug administration.