Evaluation of XYA02 in Patients With Advanced Solid Tumors (NCT07670312) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Evaluation of XYA02 in Patients With Advanced Solid Tumors
Australia190 participantsStarted 2026-07-15
Plain-language summary
This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed informed consent form(s) (ICFs) obtained at Screening.
. Has an eligible relapsed/refractory tumor with measurable disease based on RECIST 1.1 at Screening.
. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.
. Platelet (PLT) count ≥100,000/mcL at Screening.
. Hemoglobin ≥9.5 g/dL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.
. Absolute neutrophil count (ANC) ≥1,500/mcL at Screening.
. Estimated creatinine clearance (CrCl) \>60 mL/min at Screening. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.
Exclusion criteria
. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Treatment Emergent Adverse Events of XYA02
Timeframe: From enrollment for a minimum of 16 weeks
2
Duration of Treatment Emergent Adverse Events of XYA02
Timeframe: From enrollment for a minimum of 16 weeks
3
Severity of Treatment Emergent Adverse Events of XYA02
Timeframe: From enrollment for a minimum of 16 weeks
4
Determine the Maximum Tolerated Dose (MTD) of XYA02
Timeframe: From enrollment to a minimum of 16 weeks per participant
. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \< 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.
. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.
. Has a QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 millisecond (ms) in males and \> 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.
. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.
. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.
. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.
. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.