Status:
RECRUITING
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Lead Sponsor:
Alterome Therapeutics, Inc.
Conditions:
Cancer
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06533059
Start Date
August 22 2024
End Date
December 29 2027
Last Update
November 26 2025
Active Locations (51)
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1
Research Site
La Jolla, California, United States, 92093
2
Research Site
Los Angeles, California, United States, 90095
3
Research Site
Denver, Colorado, United States, 80218
4
Research Site
Sarasota, Florida, United States, 34232