Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06622226 | RECRUITING | Non Hodgkin Lymphoma

A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Sponsor:

Ono Pharmaceutical Co. Ltd

Brief Summary:

ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL. This study is Phase1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (biomarkers) and efficacy of ONO-7018 in patients with relapsed or refractory NHL.

Condition or disease

Non Hodgkin Lymphoma

Intervention/treatment

ONO-7018

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) in Japan
Actual Study Start Date : 2024-11-25
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2029-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Patient with histologically/cytologically confirmed diagnosis of any of the subtypes of B-cell NHL or T-cell NHL defined below as documented by medical records and with histology based on criteria established by the World Health Organization (Swerdlow 2017)
  • 2. Relapsed or refractory patient who is refractory or intolerant to standard therapy or for whom, in the opinion of the investigator, there is no appropriate treatment for the primary disease.
  • 3. Patient who has measurable disease
  • 4. Eastern Cooperative Oncology Group Performance Status 0 to 2
  • 5. Life expectancy of at least 3 months
Exclusion Criteria
  • 1. 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
  • 2. Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
  • 3. Prior treatment with a MALT1 inhibitor
  • 4. Patient is unable to swallow tablets
A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Location Details

NCT06622226

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Japan, Aichi

Nagoya City University Hospital

Mr. Nagoya, Aichi, Japan,

RECRUITING

Japan, Rubber

National Hospital Organization Shibukawa Medical Center

shi is not kava-yes, rubber, Japan,

NOT YET RECRUITING

Japan, Hiroshima

Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital

Hiroshima, Hiroshima, Japan,

RECRUITING

Japan, Miyagi

National Hospital Organization Sendai Medical Center

Sendai-yes, Miyagi, Japan,

RECRUITING

Japan, Tokyo

The Cancer Institute Hospital of JFCR

small talk, Tokyo, Japan,

RECRUITING

Japan,

National Hospital Organization Osaka National Hospital

Osaka, Japan,