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NCT05515406TerminatedPhase 1

A Study to Investigate the Safety, Tolerability, PK, PD, and Efficacy of ONO-7018 in Patients With R/R NHL or CLL

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

Source: ClinicalTrials.gov · Last updated 29 May 2026

Reason given: The study was terminated due to a strategic decision to discontinue development.

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
9 (actual)
First submitted
18 Aug 2022
Start date
13 Feb 2023
Primary completion date
13 Aug 2025
Lead sponsor
Ono Pharmaceutical Co., Ltd.
NCT number
NCT05515406

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with a MALT1 inhibitor
  • Patient receiving any other investigational drug within 4 weeks prior to study entry

Other illness

  • History of lymphoid malignancy other than those allowed per inclusion criteria
  • Patient with systemic and active infection
  • 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

Other

  • Patient with central nervous system involvement
  • Patient is unable to swallow tablets
  • Patient is found to be otherwise ineligible for the study by the investigator or sub investigator

Who the study is looking for

  • Patient aged ≥ 18 years
  • Written informed consent by the patient or the patient's legally authorized representative
  • Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
  • Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
  • Patient who has measurable disease
  • All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
  • Eastern Cooperative Oncology Group Performance Status 0 to 2
  • Adequate bone marrow, renal and hepatic functions

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of CincinnatiCincinnatiUnited StatesUnknown status
Baylor Scott & White Research InstituteDallasUnited StatesUnknown status
Summit Medical GroupFlorham ParkUnited StatesUnknown status
Leo Jenkins Cancer Center/ECU School of MedicineGreenvilleUnited StatesUnknown status
MD Anderson Cancer CenterHoustonUnited StatesUnknown status
AMR Kansas CityKansas CityUnited StatesUnknown status
Sarah Cannon Research InstituteNashvilleUnited StatesUnknown status
University of PennsylvaniaPhiladelphiaUnited StatesUnknown status
Thomas Jefferson UniversityPhiladelphiaUnited StatesUnknown status
Jonsson Comprehensive Cancer CenterSanta MonicaUnited StatesUnknown status
Northwest Medical SpecialitiesTacomaUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.