Testing EXS73565 for patients with relapsed or refractory B-cell cancers
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
This study is testing a new oral medication called EXS73565 to see if it can help adults with B-cell cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exscientia AI Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Madrid and 3 other locations) |
| Trial ID | NCT06980116 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the oral medication EXS73565 in patients with relapsed or refractory B-cell malignancies. Participants will be adults aged 18 and older who have been diagnosed with specific types of B-cell cancers and have not responded to standard treatments. The study will involve administering EXS73565 as a single agent to assess its effects on the targeted malignancies.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory B-cell malignancies who have exhausted standard treatment options.
Not a fit: Patients with active central nervous system malignancies or those with concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting B-cell malignancies, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid and 3 other locations
- 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)
Study contacts
- Study coordinator: Exscientia AI Ltd.
- Email: clinicaltrials@recursion.com
- Phone: 385-374-1724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.