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A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years at the time of signing the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.
• Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy
Locations
Other Locations
Georgia
LLC ARENSIA Exploratory Medicine
RECRUITING
Tbilisi
Greece
Laiko General Hospital of Athens
RECRUITING
Athens
University General Hospital of Patras
RECRUITING
Pátrai
General Hosptial of Thessaloniko G. Papanikolaou
RECRUITING
Thessaloniki
Poland
Pratia MCM
RECRUITING
Krakow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologi (Copernicus Memorial Hospital)
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Aidport Sp. z o.o. - PPDS
RECRUITING
Skórzewo
Republic of Moldova
IMSP Institute of Oncology, ARENSIA Exploratory Medicine
RECRUITING
Chisinau
Spain
Hospital Beata Maria Ana
RECRUITING
Madrid
Hospital Fundación Jiménez Diaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
MD Anderson Cancer Center Madrid
RECRUITING
Madrid
Clinica Universidad de Navarra
RECRUITING
Pamplona
Ukraine
Medical Center of LLC ARENSIA Exploratory Medicine
RECRUITING
Kyiv
United Kingdom
St James's University Hospital
RECRUITING
Leeds
University Hospitals Plymouth NHS Trust (Derriford Hospital)