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

Running, not enrolling · Phase 1

Conditions studied: Cancer, Breast Cancer, Endometrial Cancer, Metastatic Cancer, Advanced Solid Tumor

In brief

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

Key facts

Study ID

NCT06533059

Run by

Alterome Therapeutics, Inc.

People needed

110

Starts

2024-08-22

Expected to finish

2027-12-29

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — La Jolla, California, United States
• Research Site — Denver, Colorado, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Houston, Texas, United States
• Research Site #2 — San Antonio, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Fairfax, Virginia, United States
• Research Site — Madison, Wisconsin, United States
• Research Site — Randwick, New South Wales, Australia
• Research Site — Malvern, Victoria, Australia
• Research Site — Nedlands, Western Australia, Australia
• Research Site — Caen, France
• Research Site — Villejuif, France
• Research Site — Kyoto, Japan
• Research Site — Tokyo, Japan
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Barcelona, Spain
• Research Site — Barcelona, Spain
• Research Site — Madrid, Spain
• Research Site — Madrid, Spain

Full record on ClinicalTrials.gov

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