Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing whether AMT-676 can be given together with standard colorectal-cancer treatments such as chemotherapy plus bevacizumab or cetuximab. The trial will also examine how the body processes AMT-676 (pharmacokinetics) and whether it triggers an immune response against the drug.
The idea is that adding AMT-676 could be tolerable and might improve tumour control, but this trial is mainly measuring side effects and serious side effects, along with some assessment of efficacy. The record does not state a separate comparison treatment or a specific improvement in survival or time before the cancer grows.
Worth knowing: The main outcome is safety, so the study is not designed primarily to show that AMT-676 helps people live longer or keeps the cancer controlled.
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 | NCT07474727 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 180 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Multitude Therapeutics Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug AMT-676
- Drug 5-FU
- Drug Leucovorin
- Drug Bevacizumab
- Drug Cetuximab
- Drug Irinotecan
- Drug Oxaliplatin
What it is measuring
AE & SAE
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 study is an open, multi-center, phase II study, aiming to evaluate the safety, tolerability and efficacy of AMT-676 combined with 5-fluorouracil, leucovorin, bevacizumab (or cetuximab) in participants with advanced colorectal cancer, and to assess the PK(Pharmacokinetic) characteristics and immunogenicity of AMT-676.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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
- Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements
- Patients with pathologically confirmed, unresectable advanced colorectal adenocarcinoma
- Patients must have at least one measurable lesion as per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy ≥6 months
- Patients must have adequate organ function
- Male and female individuals with child bearing potential must agree to take effective contraceptive measures from the moment they sign the informed consent form until 6 months after the last administration of the study drug
- WCBP(Women of Child-Bearing Potential) must have a negative serum pregnancy test within 7 days prior to first dose of the IMP
- Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 3 months and 6 months, respectively, after the last dose of the IMP(Investigational Medicinal Product)
- Availability of tumor tissue sample
Exclusion Criteria
- Prior treatment with any same target
- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP
- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1
- Major surgery within 28 days pr…
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 19 sites. 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 NCT07474727, registered by Multitude Therapeutics 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.