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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of JMT203 in Patients With Cancer Cachexia

An Open-label, Multi-center, Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia

A Study of JMT203 in Patients With Cancer Cachexia (NCT06868849) is a Phase 1 interventional studying Colorectal Cancer and Non Small Cell Lung Cancer, sponsored by Shanghai JMT-Bio Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Colorectal Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 130 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Colorectal Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Who May Qualify: 1. Age ≥ 18 years old; 2. Voluntarily participate in the study and sign the willing to sign a consent form form; 3. 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; 4. 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; 5. 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); 6. your organs (liver, kidneys, etc.) are working well enough based on blood tests, meeting relevant laboratory test standards: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Inclusion Criteria: 1. Age ≥ 18 years old; 2. Voluntarily participate in the study and sign the informed consent form; 3. 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; 4. 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; 5. 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); 6. 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. 7\. Eastern Cooperative Oncology Group Performance Status (ECOG PS)score: ≤2; 8. Estimated survival ≥4 months; 9. 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. Exclusion Criteria: 1. Presence of reversible causes leading to decreased food intake; 2. Patients with dysphagia or poor food digestion and absorption, including gastrointestinal obstruction, active inflammatory bowel disease, or short bowel syndrome; 3. 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); 4. Patients receiving tube feeding or parenteral nutrition therapy during the screening period; 5. 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.; 6. 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; 7. Patients with a BMI exceeding 30 kg/m²; 8. 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; 9. Patients who have received other clinical study medications within 4 weeks or 5 half-lives (whichever is shorter) before the first study drug administration; 10. Patients with severe infections requiring intravenous antibiotics, antivirals, or antifungals during the screening period; 11. 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; 12. 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); 13. 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; 14. History of severe cardiovascular disease, including but not limited to: 1. Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.; 2. 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; 3. New York Heart Association functional class ≥III or left ventricular ejection fraction (LVEF) \<50%; 15. Patients with severe immune deficiency or a history of organ transplantation; 16. Patients with recent (within the past year) or current depression or suicidal ideation/tendencies; 17. Known allergy to JMT203 or its components; 18. History of severe allergic reactions or uncontrollable allergic asthma; 19. Patients deemed unsuitable for participation in this clinical study by the investigator for other reasons.

Treatments Being Tested

DRUG

JMT203 Injection

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).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Sir run run shaw Hospital
Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06868849), the sponsor (Shanghai JMT-Bio Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06868849 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06868849?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06868849?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06868849. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06868849. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.