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

Alterome Therapeutics, Inc.

Status and phase

Enrolling

Phase 1

Conditions

Metastatic Cancer

Endometrial Cancer

Breast Cancer

Advanced Solid Tumor

Cancer

Treatments

Drug: ALTA2618

Study type

Interventional

Funder types

Industry

Identifiers

NCT06533059

2618-001

Details and patient eligibility

About

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

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.