Recruiting nowPhase 2
What this trial is trying to do
The trial asks whether six months of AMB-05X can clear circulating tumour DNA (ctDNA)—a blood signal of possible remaining cancer—after curative-intent treatment for colorectal cancer. The treatment’s mechanism is not described here, so the researchers are testing its effect rather than a specified biological process.
The researchers hope that ctDNA clearance will indicate a lower risk of the cancer returning, and they will also estimate disease-free and overall survival over two years. Because the trial has no comparison group, it cannot show whether AMB-05X is better than observation or another standard approach; it will also assess safety and tolerability.
Worth knowing: This is a small, non-randomised study of 15 people, and its main measure—ctDNA clearance—is a surrogate marker rather than proof of longer survival.
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 | NCT06617858 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 15 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | M.D. Anderson Cancer Center |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug AMB-05X
What it is measuring
Safety and Adverse Events (AEs)
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
Primary Objective:
To determine ctDNA clearance rate at 6 months after treatment with AMB-05X in patients with stages I-IV CRC who have ctDNA(+) status after completion of standard of care, curative-intent therapies.
Exploratory Objectives:
To estimate 2-year DFS in patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies) upon treatment with 6 months of AMB-05X.
To estimate 2-year OS in patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies) upon treatment with 6 months of AMB-05X.
To determine the safety and tolerability of AMB-05X patients with stage I-IV CRC with detectable ctDNA after completion of standard of care, curative-intent therapies.
To characterize the pharmacokinetic profile of AMB-05X in patients with stage I-IV CRC who have ctDNA(+) MRD.
To correlate patterns of ctDNA change with clinical outcomes following treatment with AMB05X in patients with CRC who have detectable ctDNA after completion of standard therapies.
To associate clinical outcomes with PK, PD, anti-drug antibodies, and biomarkers obtained from tissue and blood samples.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
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
1. Histologic or pathologic confirmation of adenocarcinoma of the colon or rectum.
2. Completion of any curative intent therapies resulting in no evidence of disease (e.g., R0 resection) for stage I – IV CRC and has completed all planned adjuvant/standard therapies per the discretion of the evaluating clinician.
3. No evidence of measurable radiographic disease according to RECIST 1.1 criteria (Eisenhauer et al. Eur. J Cancer 2009) and/or clinically detectable disease (i.e., via endoscopy if utilized as part of standard of care assessment) at least 28 days after completion of all planned standard of care treatment.
4. A positive ctDNA assay (Signatera) at least 28 days after completion of all planned standard of care treatment. Assays performed at external institutions are accepted.
5. Adequate organ and marrow function as defined below:
1. absolute neutrophil count: ≥1,000/mcL
2. platelets: ≥75,000/mcL
3. hemoglobin: .9.0 g/dL
4. total bilirubin: ≤ institutional upper limit of normal (ULN)
5. AST(SGOT)/ALT(SGPT): ≤1.5 × institutional ULN
6. Creatinine clearance ≥50 mL/min. Creatinine clearance (CrCl) to be estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = [(140 – age) x (weight in kg) ÷ [72 x (serum creatinine in mg/dL)] [0.85 if female]
6. ECOG performance status (PS) of 0 or 1 (Appendix A).
7.
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: United States.
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 NCT06617858, registered by M.D. Anderson Cancer Center 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.