Clinical trial NCT06622226: A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non Hodgkin Lymphoma
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-10-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Dose-limiting toxicities
timeFrame: up to 3 weeks after the first dose
measure: Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Up to 28 days after the last dose
Secondary outcomes:
measure: Plasma Concentration of ONO-7018
timeFrame: up to 16 weeks after the first dose
measure: Maximum observed concentration (Cmax)
timeFrame: up to 16 weeks after the first dose
measure: Time to Cmax (Tmax)
timeFrame: up to 16 weeks after the first dose
measure: Area under the concentration-time curve to the end of the dosing period (AUCtau)
timeFrame: up to 16 weeks after the first dose
measure: Elimination half-life (T1/2)
timeFrame: up to 16 weeks after the first dose
measure: Predose trough concentration (Ctrough)
timeFrame: up to 16 weeks after the first dose
measure: Overall Response Rate (ORR)
timeFrame: through study completion, an average of 1 year
measure: Complete response rate (CRR)
timeFrame: through study completion, an average of 1 year
measure: Best overall response (BOR)
timeFrame: through study completion, an average of 1 year
measure: Duration of response (DOR)
timeFrame: through study completion, an average of 1 year
measure: Time to response (TTR)
timeFrame: through study completion, an average of 1 year
measure: Progression-free survival (PFS)
timeFrame: through study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: through study completion, an average of 1 year
measure: Percent change of tumor volume
timeFrame: through study completion, an average of 1 year
measure: Maximum percent reduction of tumor volume
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Shibukawa-shi
country: Japan
facility: National Hospital Organization Shibukawa Medical Center
state: Gumma
city: Hiroshima-shi
country: Japan
facility: Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital
state: Hiroshima
city: Sendai-shi
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miyagi
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of JFCR
state: Tokyo
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: