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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05515406
• Other study ID #: ONO-7018-01
• Status: Recruiting
• Phase: Phase 1
• Start date: February 13, 2023
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Ono Pharmaceutical Co. Ltd
• Contact: Ono Pharma USA, Inc.
• Email: clinical_trial[@]ono-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• ONO-7018
ONO-7018 tablet(s) are administered orally
• ONO-7018
ONO-7018 tablet(s) are administered orally

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Summit Medical Group	Florham Park	New Jersey
United States	Leo Jenkins Cancer Center/ECU School of Medicine	Greenville	North Carolina
United States	AMR Kansas City	Kansas City	Missouri
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Jonsson Comprehensive Cancer Center	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate of Maximum Tolerated Dose (MTD)	MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment	Up to 3 weeks
Primary	Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)	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.	Through study completion, an average of 1 year
Secondary	Plasma Concentration of ONO-7018	Plasma concentration will be assessed to evaluate Pharmacokinetics	Up to 48 weeks
Secondary	Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])	Antitumor activity of ONO-7018 as measured by ORR will be assessed according to the response criteria for Lymphoma.Lymphoma.	Through study completion, an average of 1 year
Secondary	Antitumor Activity of ONO-7018 (Duration of Response [DOR])	Antitumor activity of ONO-7018 as measured by DOR will be assessed according to the response criteria for Lymphoma.	Through study completion, an average of 1 year
Secondary	Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])	Antitumor activity of ONO-7018 as measured by PFS will be assessed according to the response criteria for Lymphoma.	Through study completion, an average of 1 year
Secondary	Antitumor Activity of ONO-7018 (Overall Survival [OS])	Antitumor activity of ONO-7018 as measured by OS will be assessed.	Through study completion, an average of 1 year