2026-05-19
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
PhasePhase 1→Phase 1/2
Primary completion date2026-05-01→2027-08-14
Completion date2028-05-01→2029-05-15
Enrollment target130→307
Study arms1→4
InterventionsJMT203 Injection (Drug)→JMT203 Injection (Drug), JMT203 Injection (Drug)
Eligibility criteria+76 characters
[...] articipate in the study and sign the informed consent form;
Inclusion Criteria:
Age ≥ 18 years old;
Voluntarily participate in the study and sign the informed consent form;
Malignant solid tumors confirmed histologically or cytologic [...] ession within 28 days prior to the first drug administration:
Dose escalation ,and expansion phase (Phase Ia): Thethe investigator predictsestimates that therethe participant will benot norequire needa switch to changeanother theanticancer anti-tumor treatment regimentherapy due to disease progression withinduring the first dosingtreatment cycle (21 days).
For the [...] [...]
Secondary endpoints13 entries, revised
Phase Ia: The PD indicators include β-hydroxybutyric acid.
Phase Ia: Average change in body weight from baseline at each assessment timepoint within 12 weeks.
Phase IbII: Average change in the skeletal muscle index (SMI) of the t [...] computed tomography (CT), from baseline to 12 weeks.
Phase IbII: Average change in the severity of anorexia (based on the F [...] CT-A/CS]) from baseline to each assessment timepoint.
Phase IbII: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Phase IbII: Blood concentration of JMT203;
Phase Ib: PD indicators include β-hydroxybutyric acid.
P [...] [...]
Primary endpoints5 to 6 entries
Phase II: RP3D
Study description+282 characters
[...] study of JMT203 in patients with cancer cachexia, and Phase IbII, which is a cohortmulticenter, randomized, double-expansionblind, placebo-controlled clinical study of JMT203 in the same patient population.
The phase II stage includes three cohorts: Cohort A (participants with colorectal cancer cachexia), Cohort B (participants with pancreatic cancer cachexia), and Cohort C (participants with cachexia from other solid tumors) .
The primary objectives of Phase Ia are to assess the safety/ [...] he recommended dose for expansion (RDE) of JMT203.
In Phase IbII, the primary objectives include evaluating [...] [...]