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

Phase 1

Active, not recruiting

• Conditions: Non Hodgkin Lymphoma
• Interventions: Drug: ONO-7018

• Registration Number: NCT06622226
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-09-29
• Study First Posted: 2024-10-02
• Study Start: 2024-11-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-03-25
• Primary Completion: 2027-07-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluation of Tolerability	ONO-7018	Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicities	up to 3 weeks after the first dose	Observed toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 to assess the tolerability of ONO-7018.
Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	Up to 28 days after the last dose	Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration of ONO-7018	up to 16 weeks after the first dose	Plasma concentration will be assessed to evaluate Pharmacokinetics.
Maximum observed concentration (Cmax)	up to 16 weeks after the first dose	To assess the PK profile of ONO-7018
Time to Cmax (Tmax)	up to 16 weeks after the first dose	To assess the PK profile of ONO-7018
Area under the concentration-time curve to the end of the dosing period (AUCtau)	up to 16 weeks after the first dose	To assess the PK profile of ONO-7018
Elimination half-life (T1/2)	up to 16 weeks after the first dose	To assess the PK profile of ONO-7018
Predose trough concentration (Ctrough)	up to 16 weeks after the first dose	To assess the PK profile of ONO-7018
Overall Response Rate (ORR)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.
Complete response rate (CRR)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by CRR will be assessed according to the response criteria for Lymphoma.
Best overall response (BOR)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by BOR will be assessed according to the response criteria for Lymphoma.
Duration of response (DOR)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.
Time to response (TTR)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by TTR will be assessed according to the response criteria for Lymphoma.
Progression-free survival (PFS)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.
Overall survival (OS)	through study completion, an average of 1 year	Antitumor activity of ONO-7018 as measured by OS will be assessed.
Percent change of tumor volume	through study completion, an average of 1 year	Percent change of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.
Maximum percent reduction of tumor volume	through study completion, an average of 1 year	Maximum percent reduction of tumor volume will be assessed according to the response criteria for Lymphoma in order to evaluate antitumor activity of ONO-7018.

Trial Locations

Locations (6)

Nagoya City University Hospital; 🇯🇵 Nagoya-shi, Aichi, Japan

Hiroshima Red Cross Hospital Atomic-bomb Survivors Hospital; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

National Hospital Organization Shibukawa Medical Center; 🇯🇵 Shibukawa-shi, Gumma, Japan

National Hospital Organization Sendai Medical Center; 🇯🇵 Sendai-shi, Miyagi, Japan

The Cancer Institute Hospital of JFCR; 🇯🇵 Koto-ku, Tokyo, Japan

National Hospital Organization Osaka National Hospital; 🇯🇵 Osaka, Japan