Recruiting nowPhase 2
| Registry number | NCT07670312 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 190 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | XYone Therapeutics, Inc |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological XYA02
What it is measuring
Frequency of Treatment Emergent Adverse Events of XYA02
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
XYA02 is an antibody drug conjugate (ADC) being developed for the treatment of malignant tumors. This is a first-in-human, dose-escalating clinical study divided into 2 parts: the Dose Escalation Part (Part 1) and the Dose Expansion Part (Part 2).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Already 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
1. Signed informed consent form(s) (ICFs) obtained at Screening.
2. Has an eligible relapsed/refractory tumor with measurable disease based on RECIST 1.1 at Screening.
3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.
5. Platelet (PLT) count ≥100,000/mcL at Screening.
6. Hemoglobin ≥9.5 g/dL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.
7. Absolute neutrophil count (ANC) ≥1,500/mcL at Screening.
8. Estimated creatinine clearance (CrCl) >60 mL/min at Screening. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.
10. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.
11. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.
12. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.
14. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening.
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 5 sites. Listed in: Australia.
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 NCT07670312, registered by XYone 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.