BridgeMD
New treatment option for Non Small Cell Lung Cancer
Official title A Study of JMT203 in Patients With Cancer Cachexia
ClinicalTrials.gov ID: NCT06868849
What this study is testing
What is JMT203 Injection?
JMT203 Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
- Malignant solid tumors confirmed histologically or cytologically, with ongoing or completed anti-tumor treatment, and no significant tumor...
You likely can't join 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...
- Patients with cachexia caused by clearly identified other causes, such as severe chronic obstructive pulmonary disease, uncontrolled thyroid disease...
- 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...
- Initiation of systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of other similar drugs) or other immunosuppressive therapies...
See the full eligibility criteria
Who can join
- 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;
- 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，and the...
- Cohort A (participants with colorectal cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected second-line standard anticancer therapy, with no more...
- Cohort B (participants with pancreatic cancer cachexia): Must meet the following treatment status: currently receiving or about to initiate investigator-selected first-line standard anticancer therapy, with no more than...
- Cohort C (participants with cachexia from other solid tumors): Currently receiving or have completed investigator-selected standard anticancer therapy, with no more than three prior lines of therapy.
- 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...
- Adequate organ function, meeting relevant laboratory test standards （without transfusion or hematopoietic growth factor support within 14 days prior to testing）:
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: ≤1;
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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.;
- Occurrence of acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of grade 3 or higher within 6 months before the first study drug administration;
- New York Heart Association functional class ≥III or left ventricular ejection fraction (LVEF) \<50%;
- Patients with severe immune deficiency or a history of organ transplantation;
- Patients with recent (within the past year) or current depression or suicidal ideation/tendencies;
- Known allergy to JMT203 or its components;
- History of severe allergic reactions or uncontrollable allergic asthma;
- Patients deemed unsuitable for participation in this clinical study by the investigator for other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.