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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516869-36-00 | EU Trial (CTIS) Number | ||
| 2022-003475-42 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXS73565 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXS73565 | Drug | EXS73565 oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to 282 days | |
| Number of Participants With Dose-limiting toxicities (DLTs) | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration (Tmax) of EXS73565-001 | 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 | Up to 253 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Exscientia AI Ltd. | Contact | 385-374-1724 | clinicaltrials@recursion.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LLC ARENSIA Exploratory Medicine | Recruiting | Tbilisi | 119 | Georgia | ||
| IMSP Institute of Oncology, ARENSIA Exploratory Medicine |
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| Maximum Concentration (Cmax) of EXS73565-001 | Up to 253 days |
| Overall Response Rate (ORR) | Up to 434 days |
| Progression Free Survival | Up to 434 days |
| Duration of Response | Up to 434 days |
| Time to Respond | Up to 434 days |
| Time to Progression | Up to 434 days |
| Overall Survival | 12 and 24 months |
| Recruiting |
| Chisinau |
| MD-2025 |
| Moldova |
| Hospital Beata Maria Ana | Recruiting | Madrid | 28007 | Spain |
| Hospital Fundación Jiménez Diaz | Recruiting | Madrid | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Medical Center of LLC ARENSIA Exploratory Medicine | Recruiting | Kyiv | 01135 | Ukraine |
| St James's University Hospital | Recruiting | Leeds | United Kingdom |
| University Hospitals Plymouth NHS Trust (Derriford Hospital) | Recruiting | Plymouth | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D020522 | Lymphoma, Mantle-Cell |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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