Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
- Registration Number
- NCT06980116
- Lead Sponsor
- Exscientia AI Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EXS73565 EXS73565 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (3)
Hospital Fundación Jiménez Diaz
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom