Recruiting NCT06980116
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EXS73565.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Georgia, Moldova, Spain, Ukraine, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug EXS73565
EXS73565 oral administration
Primary outcome measures
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 282 days]
- Number of Participants With Dose-limiting toxicities (DLTs) [Time frame: Up to 28 days]
Secondary outcome measures (9)
- Time to Maximum Concentration (Tmax) of EXS73565-001 [Time frame: 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 [Time frame: Up to 253 days]
- Maximum Concentration (Cmax) of EXS73565-001 [Time frame: Up to 253 days]
- Overall Response Rate (ORR) [Time frame: Up to 434 days]
- Progression Free Survival [Time frame: Up to 434 days]
- Duration of Response [Time frame: Up to 434 days]
- Time to Respond [Time frame: Up to 434 days]
- Time to Progression [Time frame: Up to 434 days]
- Overall Survival [Time frame: 12 and 24 months]
Eligibility criteria
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, marginal zone lymphoma, or waldenström macroglobulinaemia.
- 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 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 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 4 centers
- Hospital Beata Maria Ana — Madrid
- Hospital Fundación Jiménez Diaz — Madrid
- Hospital Universitario HM Sanchinarro — Madrid
- Clinica Universidad de Navarra — Pamplona
United Kingdom · 2 centers
- St James's University Hospital — Leeds
- University Hospitals Plymouth NHS Trust (Derriford Hospital) — Plymouth
Georgia · 1 center
- LLC ARENSIA Exploratory Medicine — Tbilisi
Moldova · 1 center
- IMSP Institute of Oncology, ARENSIA Exploratory Medicine — Chisinau
Ukraine · 1 center
- Medical Center of LLC ARENSIA Exploratory Medicine — Kyiv
Identifiers
NCT: NCT06980116 · EXS73565-001 · 2024-516869-36-00 · 2022-003475-42