A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL

ONO-7018-01

This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).

2023-02-13

2027-12-01

2027-12-01

Recruiting

Early phase I

54

Inclusion Criteria: 1. Patient aged ≥ 18 years 2. Written informed consent by the patient or the patient's legally authorized representative 3. Patient with histologically/cytologically confirmed diagnosis of NHL or CLL 4. Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit 5. Patient who has measurable disease 6. All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy 7. Eastern Cooperative Oncology Group Performance Status 0 to 2 8. Adequate bone marrow, renal and hepatic functions Exclusion Criteria: 1. History of lymphoid malignancy other than those allowed per inclusion criteria 2. Patient with central nervous system involvement 3. Patient with systemic and active infection 4. Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results 5. Prior treatment with a MALT1 inhibitor 6. Patient receiving any other investigational drug within 4 weeks prior to study entry 7. Patient is unable to swallow tablets 8. Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}

2024-05-03