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Recruiting Phase 1 NCT06533059

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

Phase 1 – testing safety in a small group of people
Conditions: Cancer Breast Cancer Endometrial Cancer Metastatic Cancer Advanced Solid Tumor

Sponsor: Alterome Therapeutics, Inc.

trial.available_in: БГ
Overview
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Description
This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
Who can participate
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 Other inclusion/exclusion criteria may apply.
Locations 8
Australia (1)
Research Site
Blacktown , New South Wales
France (1)
Research Site
Caen
Japan (1)
Research Site
Kyoto
South Korea (1)
Research Site
Seoul
Spain (1)
Research Site
Barcelona
Taiwan (1)
Research Site
Changhua
United Kingdom (1)
Research Site
London
United States (1)
Research Site
La Jolla , California
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.08.2024
Completion date
29.12.2027
Registry ID
NCT06533059
Source
anzctr
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