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

NCT06533059 · Alterome Therapeutics, Inc.
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Official title
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
About this study
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 the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.
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.
Study design
Enrollment target: 110 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-22
Estimated completion: 2027-12-29
Last updated: 2026-03-09
Interventions
Drug: ALTA2618
Primary outcomes
  • Adverse Events (Up to 39 months)
  • Dose Limiting Toxicities (21 days)
Sponsor
Alterome Therapeutics, Inc. · industry
Contacts & investigators
ContactAlterome Clinical Trial Contact Center · contact · clinical.trials@alterome.com · 619-768-8189
InvestigatorStudy Medical Director · study_director, Alterome Therapeutics
All locations (51)
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La Jolla, California, United States
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Los Angeles, California, United States
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Denver, Colorado, United States
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Sarasota, Florida, United States
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Atlanta, Georgia, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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St Louis, Missouri, United States
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Mineola, New York, United States
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New York, New York, United States
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Maumee, Ohio, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Madison, Wisconsin, United States
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Blacktown, New South Wales, Australia
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Randwick, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Malvern, Victoria, Australia
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Nedlands, Western Australia, Australia
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Caen, France
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Dijon, France
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Saint-Herblain, France
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Villejuif, France
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Kyoto, Japan
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Matsuyama, Japan
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Shizuoka, Japan
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Tokyo, Japan
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Valencia, Spain
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Changhua, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Sutton, United Kingdom
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors · TrialPath