The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed/refractory B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
EXS73565 oral administration
LLC ARENSIA Exploratory Medicine
Tbilisi, Georgia
RECRUITINGIMSP Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, Moldova
RECRUITINGHospital Beata Maria Ana
Madrid, Spain
RECRUITINGHospital Fundación Jiménez Diaz
Madrid, Spain
RECRUITINGHospital Universitario HM Sanchinarro
Madrid, Spain
RECRUITINGClinica Universidad de Navarra
Pamplona, Spain
RECRUITINGMedical Center of LLC ARENSIA Exploratory Medicine
Kyiv, Ukraine
RECRUITINGSt James's University Hospital
Leeds, United Kingdom
RECRUITINGUniversity Hospitals Plymouth NHS Trust (Derriford Hospital)
Plymouth, United Kingdom
RECRUITINGNumber of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 282 days
Number of Participants With Dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Time to Maximum Concentration (Tmax) of EXS73565-001
Time frame: Up to 253 days
Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001
Time frame: Up to 253 days
Maximum Concentration (Cmax) of EXS73565-001
Time frame: Up to 253 days
Overall Response Rate (ORR)
Time frame: Up to 434 days
Progression Free Survival
Time frame: Up to 434 days
Duration of Response
Time frame: Up to 434 days
Time to Respond
Time frame: Up to 434 days
Time to Progression
Time frame: Up to 434 days
Overall Survival
Time frame: 12 and 24 months
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