Recruiting nowPhase 2
| Registry number | NCT05024097 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 43 people (planned) |
| Who can join | aged 18 Years to 90 Years |
| Run by | Weill Medical College of Cornell University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Etrumadenant (AB928)
- Radiotherapy Radiation therapy
- Drug FOLFOX regimen
- Drug Zimberelimab (AB122)
What it is measuring
Number of treated patients who achieve complete pathologic response
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.
What this trial is trying to do
The researchers are testing whether short-course radiation followed by FOLFOX chemotherapy works better against rectal cancer when combined with two immune treatments: etrumadenant, which blocks adenosine signals that suppress immune cells, and zimberelimab, which blocks PD-1 to help immune cells attack cancer. The planned sequence is radiation first, then nine cycles of chemotherapy with both immune drugs.
The idea is that radiation may expose tumour material to the immune system, while the two drugs may reduce the tumour’s immune suppression and strengthen that response. The trial measures how many patients have no cancer left in the removed tissue—a complete pathologic response—rather than directly measuring longer survival, and it has no comparison group.
Worth knowing: This is a small, non-randomised Phase I–II trial, so it can assess safety and the rate of complete pathologic response but cannot reliably show that the combination is better than standard treatment.
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.
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
Enrolled patients will receive upfront (week 1) short-course radiotherapy to gross pelvic disease (25Gy in 5fx) in combination with AB928 (150 mg orally, once daily as part of a continuous dose regimen). This will be followed by consolidation chemotherapy (weeks 3-20) with mFOLFOX x9 cycles in combination with AB928 and AB122.
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
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
Inclusion Criteria
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Age ≥ 18 years
- ECOG performance status 0-1
- cT3N0 or cT1-3N1 or cT4 or cN2
- 5cm from the anal verge
- Rectal cancer amenable to total mesorectal excision
- No evidence of distant metastases
- No prior pelvic radiation therapy
- No prior chemotherapy or surgery for rectal cancer
- No infections requiring systemic antibiotic treatment
- Hgb >8.0 gm/dL, PLT > 150,000/mm3, total bilirubin ≤ 1.5x upper limit of normal, AST ≤ upper limit of normal, ALT ≤ 3x upper limit of normal
- Patients must read, agree to, and sign a statement of informed consent prior to participation in this study. Patients who do not read or understand English or eligible but must have the consent form bread to them in its entirety by an official translator.
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 3 sites. 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 NCT05024097, registered by Weill Medical College of Cornell University 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.