臨床研究等提出・公開システム

Date of registration	May. 29, 2026
Last modified on	May. 29, 2026
Trial ID	jRCT2031260167

Scientific Title	Study of IEV407 as single agent or in combination in patients with advanced HR+/HER2- breast cancer (CIEV407A12101)
Public Title	Study of IEV407 as single agent or in combination in patients with advanced HR+/HER2- breast cancer (CIEV407A12101)

Contact for Scientific Queries	Name	Moizumi Sanae
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com
Contact for Public Queries	Name	Moizumi Sanae
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 11, 2026
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Age >= 18 years old - Patients with one of the following indications: -Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at leaset one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator judgement. -Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.
	Exclusion Criteria	- Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values. - Impaired cardiac function or clinically significant cardiac disease. - Concurrent use of hormone replacement therapy. - Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women. - For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced HR+/HER2- Breast Cancer
Intervention(s)		Experimental: IEV407 Single Agent Experimental: IEV407 in combination with fulvestrant Experimental: IEV407 in combination with letrozole
Primary Outcome(s)		Incidence and severity of dose-limiting toxicities (DLTs) Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Frequency of dose interruptions, reductions and discontinuations Dose intensity

Primary Sponsor	Novartis Pharma. K.K.

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Approval Status	Approval
Date of approval	April. 15, 2026

Plan to share IPD	No

Secondary ID(s)	NCT07604571
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	Canada/Czech Republic/Denmark/France/Germany/Hong Kong/Hungary/Italy/Korea/Nethherlands/Poland/Portugal/Singapore/Spain/Taiwan/UK/United States