A Study of JMT203 in Patients With Cancer Cachexia

NCT06868849 | Recruiting Phase 1

• 1 other identifier: JMT203-001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Non Small Cell Lung Cancer; Pancreatic Cancer; Cancer Cachexia

Outcome Measures

Primary Outcomes (5)

• Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

  Up to 90 days after the last dose of JMT203

• Phase Ia: Incidence of dose-limiting toxicity (DLT) events

  Up to 21 days after the first dose of JMT203

• Phase Ia: MTD (if applicable).

  Up to 90 days post last dose

• Phase Ia: RDE.

  Up to 90 days post last dose

• Phase Ib: Average change in body weight from baseline at each assessment timepoint within 12 weeks.

  Within 12 weeks from baseline

Secondary Outcomes (13)

• Phase Ia: Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of JMT203

  Up to 90 days after the last dose of JMT203

• Phase Ia: Maximum measured plasma concentration (Cmax) of JMT203

  Up to 90 days after the last dose of JMT203

• Phase Ia: Time when Cmax occurred (Tmax) of JMT203

  Up to 90 days after the last dose of JMT203

• Phase Ia: The PD indicators include β-hydroxybutyric acid.

  Up to 12 weeks

• Phase Ia: Incidence of anti-drug antibodies (ADA).

  Up to 90 days after the last dose of JMT203

Study Arms (1)

Experimental: Dose Escalation, Dose Expansion and Cohort Expansion Phase

EXPERIMENTAL

Dose escalation - Five dose levels of JMT203 will be tested in patients with cancer cachexia according to an accelerated titration design combined with a "3+3" dose escalation scheme. If the highest predefined dose group demonstrates good safety and tolerability during dose escalation, further discussion will be held on whether to proceed to a higher dose group or to explore doses between two existing groups. Dose expansion - Based on pharmacokinetics (PK), pharmacodynamics (PD), preliminary efficacy, and safety data, 1 to 3 dose levels that are potentially effective will be selected. Cohort expansion- There are three cohorts: Cohort A: Patients with non-resectable, advanced, recurrent, or metastatic non-small cell lung cancer cachexia. Cohort B: Patients with non-resectable, advanced, recurrent, or metastatic pancreatic cancer cachexia. Cohort C: Patients with non-resectable, advanced, recurrent, or metastatic colorectal cancer and other types of cachexia. Patients with select so

Drug: JMT203 Injection

Interventions

JMT203 Injection DRUG

Drug：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).

Experimental: Dose Escalation, Dose Expansion and Cohort Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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;
• Patients who have received other clinical study medications within 4 weeks or 5 half-lives (whichever is shorter) before the first study drug administration;
• Patients with severe infections requiring intravenous antibiotics, antivirals, or antifungals during the screening period;
• Patients with difficult-to-control moderate to large amounts of serous cavity effusion, such as pericardial effusion or pleural/abdominal/pelvic effusion, within 14 days before the first study drug administration;
• Patients with a second primary active malignancy within 2 years before the first study drug administration, excluding locally curable tumors that have undergone radical treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, breast carcinoma in situ);
• Patients with active central nervous system metastases (brain metastases, carcinomatous meningitis, and spinal cord metastases), except for those with controlled lesions confirmed by imaging studies within 28 days before the first use of the investigational product;
• History of severe cardiovascular disease, including but not limited to:
• Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.;

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

Study Sites (1)

Sir run run shaw Hospital

Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Clinical Trials Information Group Officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There is no comparison group.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 11, 2025
• Study Start: May 15, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)