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Active, not recruiting Phase 1

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

NCT06533059 · tracked via the Priya Life Science France tracker
Sponsor
Alterome Therapeutics, Inc
Phase
Phase 1
Started
2024-08-22
Last updated
2026-07-15

Condition(s) studied

CancerBreast CancerEndometrial CancerMetastatic CancerAdvanced Solid Tumor

Investigational drug(s) / intervention(s)

ALTA2618

ALTA2618: Oral ALTA2618 tablets will be administered at protocol-defined dose

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Adverse Events — Up to 39 months
    Number of participants that experience treatment-emergent adverse events (TEAEs).
  • Dose Limiting Toxicities — 21 days
    Number of participants with Dose Limiting Toxicities (DLTs).

Trial sites (31)

FacilityCityRegionStatus
Research Site La Jolla California
Research Site Denver Colorado
Research Site Sarasota Florida
Research Site Boston Massachusetts
Research Site Boston Massachusetts
Research Site St Louis Missouri
Research Site Nashville Tennessee
Research Site Houston Texas
Research Site #2 San Antonio Texas
Research Site San Antonio Texas
Research Site Fairfax Virginia
Research Site Madison Wisconsin
Research Site Randwick New South Wales
Research Site Malvern Victoria
Research Site Nedlands Western 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
Research Site Taipei Taiwan
Research Site London United Kingdom
Research Site London United Kingdom
Research Site Manchester United Kingdom
Research Site Newcastle upon Tyne United Kingdom
Research Site Sutton United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06533059 on ClinicalTrials.gov ↗ ← All trials in France