Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies

Last updated: May 12, 2025
Sponsor: Exscientia AI Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

EXS73565

Clinical Study ID

NCT06980116
EXS73565-001
2024-516869-36-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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, ormarginal zone lymphoma.

  • Participants that have relapsed after standard of care or have progressed duringstandard of care or are not suitable for standard of care therapy

Exclusion

Key Exclusion Criteria:

  • Any medical or psychiatric condition that, in the view of the PrincipalInvestigator, could jeopardize or would compromise the participant's safety orability 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 forwhich the participant will be treated on this protocol within 5 years prior torandomization; participants with prior cancers may be enrolled with documentedSponsor approval.

  • Received anticancer therapy, including chemotherapy, immunotherapy, radiationtherapy (with the exception of palliative radiotherapy), biologic therapy,cancer-related hormonal therapy, or any investigational therapy within 21 days or 5half-lives (whichever is longer) before the first dose of the study treatment.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: EXS73565
Phase: 1
Study Start date:
March 31, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Hospital Fundación Jiménez Diaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

  • University Hospitals Plymouth NHS Trust

    Plymouth,
    United Kingdom

    Active - Recruiting

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