Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing whether AKY-2519 can find B7-H3, a protein on the surface of some cancer cells, and deliver either a radioactive imaging signal ([64Cu]Cu-AKY-2519) or cancer-killing alpha radiation ([225Ac]Ac-AKY-2519) to those cells. They will study how the treatment behaves in the body, its radiation dose to tissues, its side effects, and any early signs of tumour activity.
The idea is that directing radiation to B7-H3-positive tumour cells could damage them while limiting radiation to other tissues; the trial will look mainly at whether the treatment can be given safely and will record preliminary anti-tumour activity, rather than compare it with standard treatment or measure longer survival.
Worth knowing: This is a small, open-label, non-randomised Phase 1 study, so its main purpose is safety and drug behaviour, not proof that the treatment improves outcomes.
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 | NCT07887971 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 152 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Aktis Oncology, Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug [225Ac]Ac-AKY-2519 (therapeutic)
- Drug [64Cu]Cu-AKY-2519 (imaging)
What it is measuring
Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519
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 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519, as well as the preliminary anti-tumor activity of [225Ac]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
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
- Age ≥ 18 years
- Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma
- Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Adequate end-organ function
- Ability to give informed consent and comply with study requirements
- Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
Exclusion Criteria
- Prior treatment with a B7-H3 targeted therapy
- Prior treatment with a targeted radiotherapy
- Received an investigational agent within the previous 28 days
- Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days
- Impaired cardiac function or clinically significant cardiac disease
- Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
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 2 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 NCT07887971, registered by Aktis Oncology, 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.