臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 03, 2024
Last modified on	Feb. 17, 2025
Trial ID	jRCT2021240028

Scientific Title	ONO-7018-03: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 (ONO-7018-03)
Public Title	A phase 1 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

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	Medical Information Center
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Telephone	+81-120-626-190
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Suspended

Anticipated date of first enrollment		Nov. 25, 2024
Actual date of first enrollment		Nov. 27, 2024
Target sample size		24
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion 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.ECOG PS 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Non-Hodgkin Lymphoma
Intervention(s)		ONO-7018 Given as Monotherapy
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To assess the tolerability and safety of ONO-7018 in patients with relapsed or refractory NHL
Secondary Outcome(s)		To assess the efficacy of ONO-7018 in patients with relapsed or refractory NHL To assess the PK profile of ONO-7018

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Hospital Organization Sendai Medical Center Institutional Review Board
Address	2-11-12 Miyagino, Miyagino-ku, Sendai-shi, Miyagi
Telephone
E-Mail
Approval Status	Approval
Date of approval	Sept. 19, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06622226
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Feb. 17, 2025	(this page)	Changes
3	Nov. 18, 2024	Detail	Changes
2	Nov. 15, 2024	Detail	Changes
1	Oct. 03, 2024	Detail

List of change history