AzTrials
AzTrials

Non Small Cell Lung CancerPhase 1/2NCT06868849

A Study of JMT203 in Patients With Cancer Cachexia

A Phase 1/2 study testing JMT203 Injection in people with Non Small Cell Lung Cancer and Pancreatic Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JMT203 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
307 participants
Where
1 siteChina
Study dates
15 May 2024to 15 May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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 investigator estimates that the participant will not require a switch to another anticancer therapy due to disease progression during the first treatment cycle (21 days). For the Phase II portion:
  • 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 than 5 cycles of second-line therapy, and not suitable for immune checkpoint inhibitors.;
Show all 14Show fewer
  • 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 3 cycles of first-line therapy, and not suitable for targeted therapy.;
  • 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 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;
  • 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 negative serum pregnancy test within 7 days before the first drug administration.

Who cannot join

  • 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;
Show all 22Show fewer
  • 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.;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group Officer contact

86-0311-69085587

ctr-contact@cspc.cn

China1 site, 1 recruiting
  • Sir run run shaw Hospital

    Zhejiang

    Sir run run shaw Hospital

    Recruiting

Other trials in China

About this study

Official title: A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients With Cancer Cachexia

A Phase Ia/II, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT203 in Patients with Cancer Cachexia

Read the detailed description

This is a study of JMT203 in patients with cancer cachexia, comprising two parts: Phase Ia, which involves a dose-escalation and dose-expansion study of JMT203 in patients with cancer cachexia, and Phase II, which is a multicenter, randomized, double-blind, placebo-controlled clinical study. 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/tolerability of JMT203 in patients with cancer cachexia and to determine the maximum tolerated dose (MTD) (if any) and/or the recommended dose for expansion (RDE) of JMT203. In Phase II, the primary objectives include evaluating the preliminary efficacy of JMT203 at doses of 50 mg and 150 mg versus placebo over a 12-week treatment period and determining the recommended Phase 3 dose (RP3D) of JMT203.

Being tested
JMT203 Injection
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JMT203 InjectionDrug

    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).
  • JMT203 InjectionDrug

    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).
Study groups in NCT06868849
Study groupRoleWhat they receive
Experimental: Dose Escalation, Dose Expansion PhaseExperimentalDose escalation (Phase Ia) - 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 (Phase Ia) - Based on pharmacokinetics (PK), preliminary efficacy, and safety data, 1 to 3 dose levels that are potentially effective will be selected. Cohort expansion- One to three potentially effective dose groups will be selected for expansion based on PK, preliminary efficacy, and safety data, with a maximum of 24 participants per group in principle (including participants from the same dose group in the dose-escalation phase).
Receives: Drug: JMT203 Injection
Experimental: JMT203 50 mgExperimentalDouble blind phase (Phase II):JMT203 50 mg administered subcutaneously every 3 weeks over a 12-week treatment period.
Receives: Drug: JMT203 Injection
Experimental: JMT203 150 mgExperimentalDouble blind phase (Phase II):JMT203 150 mg administered subcutaneously every 3 weeks over a 12-week treatment period; Open-Label Treatment Phase (Phase II): JMT203 administered subcutaneously at 150 mg or at the RP3D (once established in this study) for up to 51 weeks.
Receives: Drug: JMT203 Injection
Experimental: PlaceboPlacebo comparatorDouble blind phase (Phase II):Placebo administered subcutaneously every 3 weeks over a 12-week treatment period;
Receives: Drug: JMT203 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 90 days after the last dose of JMT203

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

    Measured: Up to 21 days after the first dose of JMT203

  3. Phase Ia: MTD (if applicable).

    Measured: Up to 90 days post last dose

  4. Phase Ia: RDE.

    Measured: Up to 90 days post last dose

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

    Measured: Within 12 weeks from baseline

  6. Phase II: RP3D

    Measured: Approximately 1 year from baseline

Secondary outcomes (13)
  1. Phase Ia: Area under the curve from time "0" to the time of the last measurable concentration (AUC0-t) of JMT203

    Measured: Up to 90 days after the last dose of JMT203

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

    Measured: Up to 90 days after the last dose of JMT203

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

    Measured: Up to 90 days after the last dose of JMT203

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

    Measured: Up to 90 days after the last dose of JMT203

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

    Measured: Within 12 weeks from baseline

  6. Phase II: Average change in the skeletal muscle index (SMI) of the third lumbar vertebra, measured by computed tomography (CT), from baseline to 12 weeks.

    Measured: Within 12 weeks from baseline

  7. Phase II: Average change in the severity of anorexia (based on the Functional Assessment of Anorexia/Cachexia Therapy - Anorexia/Cachexia Subscale [FAACT-A/CS]) from baseline to each assessment timepoint.

    Measured: Within 12 weeks from baseline

  8. Phase II: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

    Measured: Up to 90 days after the last dose of JMT203

  9. Phase II: Blood concentration of JMT203;

    Measured: Up to 90 days after the last dose of JMT203

  10. PhaseII: Incidence of ADA.

    Measured: Up to 90 days after the last dose of JMT203

  11. PhaseII: Objective Response Rate (ORR)

    Measured: Approximately 12 weeks from baseline

  12. PhaseII: Progression-Free Survival (PFS)

    Measured: Approximately 1 year from baseline

  13. Phase II: overall survival (OS).

    Measured: Approximately up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start15 May 2024
  3. Primary completion14 Aug 2027 (estimated)
  4. Study completion15 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There is no comparison group.
Masking
Single blind
Who is masked
Participant
Enrolment
307 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868849
Sponsor's protocol ID
JMT203-001
Status last verified
May 2026
First submitted
18 Feb 2025
Last updated
22 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JMT203 Injection in people with Non Small Cell Lung Cancer and Pancreatic Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Information Group Officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). (time frame: Up to 90 days after the last dose of JMT203). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in