This study will evaluate the safety, tolerability, and efficacy of XYA02 in participants with advanced solid tumors.
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.
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.
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.
Sequential
XYA02
Biological/VaccineIV infusion
Frequency of Treatment Emergent Adverse Events of XYA02
Frequency of Treatment Emergent Adverse Events \[Safety and Tolerability\]
Duration of Treatment Emergent Adverse Events of XYA02
Length of duration of Treatment Emergent Adverse Events (start date to end date) \[Safety and Tolerability\]
Severity of Treatment Emergent Adverse Events of XYA02
Severity by grading of Treatment Emergent Adverse Events \[Safety and Tolerability\]
Determine the Maximum Tolerated Dose (MTD) of XYA02
Frequency of DLT occurring during participant exposure to XYA02
Anti-tumor activity of XYA02
Objective Response Rate (ORR) as measured by RECIST 1.1 criteria
Anti-tumor activity of XYA02
Time to response
Anti-tumor activity of XYA02
Duration of response
Anti-tumor activity of XYA02
Progression free survival
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XYone Therapeutics, Inc
Lead sponsor
Novotech (Australia) Pty Limited
Collaborator
