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

Purpose

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Conditions

Cancer
Breast Cancer
Endometrial Cancer
Metastatic Cancer
Advanced Solid Tumor

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ALTA2618	ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment	Drug: ALTA2618 Oral ALTA2618 tablets will be administered at protocol-defined dose

Recruiting Locations

Research Site
La Jolla 5363943, California 5332921 92093

Research Site
Los Angeles 5368361, California 5332921 90095

Research Site
Denver 5419384, Colorado 5417618 80218

Research Site
Sarasota 4172131, Florida 4155751 34232

Research Site
Atlanta 4180439, Georgia 4197000 30322

Research Site
Boston 4930956, Massachusetts 6254926 02114

Research Site
Boston 4930956, Massachusetts 6254926 02215

Research Site
St Louis 4407066, Missouri 4398678 63110

Research Site
Mineola 5127134, New York 5128638 11501

Research Site
New York 5128581, New York 5128638 10016

Research Site
Maumee 5162137, Ohio 5165418 43637

Research Site
Nashville 4644585, Tennessee 4662168 37203

Research Site
Houston 4699066, Texas 4736286 77030

Research Site #2
San Antonio 4726206, Texas 4736286 78229

Research Site
San Antonio 4726206, Texas 4736286 78229

Research Site
Fairfax 4758023, Virginia 6254928 22031

Research Site
Madison 5261457, Wisconsin 5279468 53792

More Details

NCT ID: NCT06533059
Status: Recruiting
Sponsor: Alterome Therapeutics, Inc.

Study Contact

Alterome Clinical Trial Contact Center
619-768-8189
clinical.trials@alterome.com

Detailed 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.