Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether JMT203 can help people with cancer cachexia, the loss of weight and muscle that can occur with cancer. The first part tests different doses for safety; the randomised phase compares 50 mg and 150 mg with placebo in people with cachexia linked to colorectal, pancreatic, or other solid cancers.
The idea is that JMT203 could improve cachexia-related outcomes compared with no active drug, but the record does not specify which clinical measures will define improvement. The study is also intended to select a dose for a later Phase 3 trial.
Worth knowing: This is an early-stage study: its first part is mainly assessing side effects and dose, and the available description does not establish whether the later phase measures longer survival, tumour control, or a specific improvement in weight or muscle.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06868849 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, blinded |
| Taking part | 307 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Shanghai JMT-Bio Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug JMT203 Injection
What it is measuring
Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
Inclusion Criteria
1. Age ≥ 18 years old;
2. Voluntarily participate in the study and sign the informed consent form;
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，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.;
- 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 investigat…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06868849, registered by Shanghai JMT-Bio Inc. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.