Clinical trial NCT06533059: A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors
Official title: AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cancer
Breast Cancer
Endometrial Cancer
Metastatic Cancer
Advanced Solid Tumor
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
Lead sponsor: Alterome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 39 months
measure: Dose Limiting Toxicities
timeFrame: 21 days
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
measure: Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)
timeFrame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose
measure: Terminal Half-Life (t1/2)
timeFrame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose
measure: Overall Response Rate (ORR)
timeFrame: Up to 39 months
measure: Duration of Response (DOR)
timeFrame: Up to 39 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 39 months
measure: Overall Survival (OS)
timeFrame: Up to 39 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Mineola
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Maumee
country: United States
facility: Research Site
state: Ohio
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site #2
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Fairfax
country: United States
facility: Research Site
state: Virginia
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Blacktown
country: Australia
facility: Research Site
state: New South Wales
city: Randwick
country: Australia
facility: Research Site
state: New South Wales
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Villejuif
country: France
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: Alterome Therapeutics
name: Study Medical Director
role: STUDY_DIRECTOR
References: