Clinical Trials in the UK / NCT06980116
Recruiting
Phase 1
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06980116 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Relapsed or Refractory B-cell MalignanciesChronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)Follicular Lymphoma (FL)Marginal Zone Lymphoma (MZL)Mantle Cell Lymphoma (MCL)Diffuse-large B-cell Lymphoma (DLBCL)Waldenstrom's Macroglobulinemia (WM)
Investigational drug(s) / intervention(s)
EXS73565
EXS73565: EXS73565 oral administration
Study 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
Key Inclusion Criteria:
* 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
Key Exclusion Criteria:
* Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
* Known central nervous system (CNS) malignancy or primary CNS lymphoma.
* Concurrent active or previous malignancy (other than the primary lymphoma/CLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.
* Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
Primary outcome measure(s)
- 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
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| LLC ARENSIA Exploratory Medicine | Tbilisi | Georgia | Recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Recruiting |
| University General Hospital of Patras | Pátrai | Greece | Recruiting |
| General Hosptial of Thessaloniko G. Papanikolaou | Thessaloniki | Greece | Recruiting |
| IMSP Institute of Oncology, ARENSIA Exploratory Medicine | Chisinau | Moldova | Recruiting |
| Pratia MCM | Krakow | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologi (Copernicus Memorial Hospital) | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie | Lublin | Poland | Recruiting |
| Aidport Sp. z o.o. - PPDS | Skórzewo | Poland | Recruiting |
| Hospital Beata Maria Ana | Madrid | Spain | Recruiting |
| MD Anderson Cancer Center Madrid | Madrid | Spain | Recruiting |
| Hospital Fundación Jiménez Diaz | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Recruiting |
| Clinica Universidad de Navarra | Pamplona | Spain | Recruiting |
| Medical Center of LLC ARENSIA Exploratory Medicine | Kyiv | Ukraine | Recruiting |
| St James's University Hospital | Leeds | United Kingdom | Recruiting |
| University Hospitals Plymouth NHS Trust (Derriford Hospital) | Plymouth | United Kingdom | Recruiting |
More Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. trials in the UK
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06980116 on ClinicalTrials.gov ↗ ← All trials in the UK