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Trial Title:
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
NCT ID:
NCT06533059
Condition:
Cancer
Breast Cancer
Endometrial Cancer
Metastatic Cancer
Advanced Solid Tumor
Conditions: Official terms:
Breast Neoplasms
Endometrial Neoplasms
Conditions: Keywords:
AKT1 E17K
Breast cancer
Breast carcinoma
Breast neoplasm
ER positive breast
HR positive breast
Triple negative breast cancer
Gynecologic cancer
Gynecologic neoplasm
Gynecologic carcinoma
Endometrial cancer
Endometrial neoplasm
Endometrial carcinoma
Cervical cancer
Cervical neoplasm
Cervical carcinoma
Ovarian cancer
Ovarian carcinoma
Ovarian neoplasm
Fallopian cancer
Fallopian carcinoma
Fallopian neoplasm
Prostate cancer
Prostate carcinoma
Prostate neoplasm
Solid tumors
AKT mutation
Mutant AKT
AKT1 mutation
AKT mutant
AKT1E17K
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ALTA2618
Description:
Oral ALTA2618 tablets will be administered at protocol-defined dose
Arm group label:
ALTA2618
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 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
August 22, 2024
Completion date:
December 29, 2027
Lead sponsor:
Agency:
Alterome Therapeutics, Inc.
Agency class:
Industry
Source:
Alterome Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06533059
