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A Study of JMT203 in Patients With Cancer Cachexia

StatusRecruiting
PhasePhase 1/2
Started2024-05-15
View on ClinicalTrials.gov ↗

Amendment history

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 [...] [...]
2025-03-09
minor
Original filing
4,033 trials monitored
See 210 trials at risk
2,904 trials monitored
See 127 trials at risk
and 1 more disease
A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia
Trial Details
NCT Number NCT06868849
Lead Sponsor Shanghai JMT-Bio Inc.
Conditions Non Small Cell Lung Cancer, Pancreatic Cancer, Cancer Cachexia, Colorectal Cancer Cachexia, Pancreatic Cancer Cachexia
Enrollment 307 participants
Start Date 2024-05-15
Primary Completion 2027-08-14 (estimated)
Study Completion 2029-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-05-22