A Phase 1/1b Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K
Research type
Research Study
Full title
AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients with Advanced Solid Tumors with AKT1 E17K Mutation
IRAS ID
1007176
Contact name
Aziz Alam
Contact email
Sponsor organisation
Alterome Therapeutics
Clinicaltrials.gov Identifier
Research summary
ALTA2618 is an investigational drug designed to target proteins produced by a specific gene mutation (AKT1 E17K mutation) that is thought to cause cancer cells to grow. ALTA2618 is designed to block this mutant protein, & thereby prevent the growth & spread of this cancer.
This first in human study will test the effects of ALTA2618 at different doses, to see if it works & also to assess how quickly ALTA2618 is absorbed in the blood & how quickly the body removes the drug
The study is divided into two parts
Phase 1 Dose Escalation
In this phase, the safety will be tested at different dose levels. The total number of participants to be included in each dose group depends on how many enrolled participants experience side effects while taking ALTA2618. Various doses will be explored until a dose level that is considered tolerable to most participants is identified.
Participants may be added to dose level groups that have been determined as tolerable & lower dose level groups that are being actively evaluated. These are called ‘backfill cohorts’.
Some participants will start their treatment with a Pharmacokinetic (PK) Lead-In Period. The purpose is to measure the amount of ALTA2618 in the blood after a single dose.
Food effect sub-study. The purpose of the sub-study is to look at whether eating food along with ALTA2618 affects how much ALTA2618 gets in the blood & how long it stays there. Approximately 6 participants will be enrolled into the food effect sub-study.
The second part of the study (Phase 1b dose expansion) will begin after an ALTA2618 dose is selected for further investigation.
This phase will enrol participants with specific types of cancer with the AKT1 E17K gene mutation into specific groups of participants. Participants with a specific type of breast cancer will enrol into Cohort A; participants with gynaecological cancers will enrol into Cohort B; &participants with all other types of solid tumour cancers will enrol into Cohort CREC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0105
Date of REC Opinion
14 May 2025
REC opinion
Further Information Favourable Opinion