Clinical trial NCT06980116: Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed or Refractory B-cell Malignancies
Lead sponsor: Exscientia AI Limited
Sponsor class: INDUSTRY
First posted: 2025-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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, 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

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 21 days or 5 half-lives (whichever is longer) before the first dose of the study treatment.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 282 days
measure: Dose-limiting toxicities (DLTs) of EXS73565-001
timeFrame: Up to 21 days
Secondary outcomes:
measure: Time to Maximum Concentration (Tmax) of EXS73565-001
timeFrame: Up to 253 days
measure: Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001
timeFrame: Up to 253 days
measure: Maximum Concentration (Cmax) of EXS73565-001
timeFrame: Up to 253 days
measure: Overall Response Rate (ORR)
timeFrame: Up to 434 days
measure: Disease Control Rate
timeFrame: Up to 434 days
measure: Progression Free Survival
timeFrame: Up to 434 days
measure: Duration of Response
timeFrame: Up to 434 days
measure: Time to Respond
timeFrame: Up to 434 days
measure: Time to Progression
timeFrame: Up to 434 days
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
Study officials:
References: