NCT06980116

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
32mo left

Started Mar 2025

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2025Dec 2028

Study Start

First participant enrolled

March 31, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

May 12, 2025

Last Update Submit

November 25, 2025

Conditions

Relapsed or Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (2)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Up to 282 days

  • Dose-limiting toxicities (DLTs) of EXS73565-001

    Up to 21 days

Secondary Outcomes (9)

  • 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

  • Disease Control Rate

    Up to 434 days

  • +4 more secondary outcomes

Study Arms (1)

EXS73565

EXPERIMENTAL
Drug: EXS73565

Interventions

EXS73565DRUG

EXS73565 oral administration

EXS73565

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital Fundación Jiménez Diaz

Madrid, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Spain

RECRUITING

St James's University Hospital

Leeds, United Kingdom

RECRUITING

University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Exscientia AI Ltd.

CONTACT

385-374-1724clinicaltrials@recursion.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)ES(2)