RecruitingPhase 1NCT06533059
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
Sponsor
Alterome Therapeutics, Inc.
Enrollment
110 participants
Start Date
Aug 22, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria3
- 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
Interventions
DRUGALTA2618
Oral ALTA2618 tablets will be administered at protocol-defined dose
Locations(51)
View Full Details on ClinicalTrials.gov
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NCT06533059
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