Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Diffuse-large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Relapsed or Refractory B-cell Malignancies, Waldenstrom's Macroglobulinemia (WM)
Conditions
Keywords
B-cell Malignancies, Chronic 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), MALT1
Brief 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.
Interventions
DRUGEXS73565
EXS73565 oral administration
Sponsors
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| 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 |
Countries
Georgia, Greece, Moldova, Poland, Spain, Ukraine, United Kingdom
Contacts
CONTACTExscientia AI Ltd.
Outcome results
None listed