Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
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
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
50 participants
Mar 31, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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, or marginal zone lymphoma.
- Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy
Exclusion Criteria4
- 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 21 days or 5 half-lives (whichever is longer) before the first dose of the study treatment.
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Interventions
EXS73565 oral administration
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06980116