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

Launched by ALTEROME THERAPEUTICS, INC. · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new medicine called ALTA2618 for adults with specific types of cancer that have a genetic mutation known as AKT1 E17K. The main goal of the study is to see how safe and well-tolerated this medication is for patients with advanced solid tumors, including breast cancer and endometrial cancer, that cannot be surgically removed or have spread to other parts of the body.

To participate in this trial, individuals must have a confirmed diagnosis of a solid tumor with the AKT1 E17K mutation and have already tried or been unable to tolerate standard cancer treatments. Participants should be between the ages of 65 and 74, have stable organ function, and be able to perform daily activities with minimal assistance. If you or someone you know meets these criteria and is interested, they will have regular check-ups to monitor their health and response to the treatment throughout the study. This trial is currently recruiting new participants.

Gender

ALL

Eligibility criteria

• 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.