A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Purpose
The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.
Conditions
- Cancer
- Breast Cancer
- Endometrial Cancer
- Metastatic Cancer
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALTA2618 |
ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment |
|
Recruiting Locations
Research Site
La Jolla, California 92093
La Jolla, California 92093
Research Site
Los Angeles, California 90095
Los Angeles, California 90095
Research Site
Denver, Colorado 80218
Denver, Colorado 80218
Research Site
Sarasota, Florida 34232
Sarasota, Florida 34232
Research Site
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Research Site
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Research Site
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Research Site
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Research Site
Mineola, New York 11501
Mineola, New York 11501
Research Site
New York, New York 10016
New York, New York 10016
Research Site
Maumee, Ohio 43637
Maumee, Ohio 43637
Research Site
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Research Site
Dallas, Texas 75251
Dallas, Texas 75251
Research Site
Houston, Texas 77030
Houston, Texas 77030
Research Site #2
San Antonio, Texas 78229
San Antonio, Texas 78229
Research Site
San Antonio, Texas 78229
San Antonio, Texas 78229
Research Site
Fairfax, Virginia 22031
Fairfax, Virginia 22031
Research Site
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT06533059
- Status
- Recruiting
- Sponsor
- Alterome Therapeutics, Inc.
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 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.