臨床研究等提出・公開システム

Date of registration	Jan. 31, 2025
Last modified on	April. 22, 2026
Trial ID	jRCT2031240650

Scientific Title	AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation
Public Title	A Study to Learn About Study Medicine ALTA2618 in Adults with AKT1 E17K-Mutant Solid Tumors

Contact for Scientific Queries	Name	Nakashima Michiyo
	Affiliation	Syneos Health Japan K.K.
	Address	12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-70-1413-9390
	E-mail	2618-001@syneoshealth.com
Contact for Public Queries	Name	Nakashima Michiyo
	Affiliation	Syneos Health Japan K.K.
	Address	12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-70-1413-9390
	E-mail	2618-001@syneoshealth.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 28, 2025
Actual date of first enrollment		June. 17, 2025
Target sample size		10
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	- Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. - Unresectable or metastatic disease. - Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage. - Evaluable or measurable disease per RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function.
	Exclusion Criteria	- Prior treatment with PI3K and/or mTOR inhibitors. - Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor. - Known condition that prohibits ability to swallow or absorb an oral medication.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Advanced solid tumors with AKT1 E17K mutation
Intervention(s)		Oral ALTA2618 tablets will be administered once daily.
Primary Outcome(s)		- Number of participants that experience treatment-emergent adverse events (TEAEs) - Number of participants with Dose Limiting Toxicities (DLTs)
Secondary Outcome(s)		- Maximum Observed Plasma Concentration (Cmax) - Time to Reach Maximum Observed Plasma Concentration (Tmax) - Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt) - Terminal Half-Life (t1/2) - Overall Response Rate (ORR), assess per RECIST 1.1 - Duration of Response (DOR), assess per RECIST 1.1 - Progression-Free Survival (PFS), assess per RECIST 1.1 - Overall Survival (OS), assess per RECIST 1.1

Primary Sponsor	Alterome Therapeutics, Inc.

Name of Certified Review Board	Cancer Institute Hospital of JFCR Institutional Review Board
Address	3-8-31, Ariake, Koto-ku, Tokyo, Tokyo
Approval Status	Approval
Date of approval	Jan. 28, 2025

Plan to share IPD	No

Secondary ID(s)	NCT06533059
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	US/Australia/Taiwan/South Korea/Spain/UK/France

History of Changes

No	Publication date
3	April. 22, 2026	(this page)	Changes
2	Jan. 30, 2026	Detail	Changes
1	Jan. 31, 2025	Detail

List of change history