NIPH Clinical Trials Search

A Study to Learn About Study Medicine ALTA2618 in Adults with AKT1 E17K-Mutant Solid Tumors

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Advanced solid tumors with AKT1 E17K mutation
Date of first enrollment	17/06/2025
Target sample size	10
Countries of recruitment	US,Japan,Australia,Japan,Taiwan,Japan,South Korea,Japan,Spain,Japan,UK,Japan,France,Japan
Study type	Interventional
Intervention(s)	Oral ALTA2618 tablets will be administered once daily.

Outcome(s)

Primary Outcome

- Number of participants that experience treatment-emergent adverse events (TEAEs) - Number of participants with Dose Limiting Toxicities (DLTs)

Secondary Outcome

- 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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.