NCT06533059

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

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Alterome Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Breast Cancer
• Endometrial Cancer
• Metastatic Cancer
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ALTA2618	Oral ALTA2618 tablets will be administered at protocol-defined dose

Timeline

• Start date: 2024-08-22
• Primary completion: 2026-12-29
• Completion: 2027-12-29
• First posted: 2024-08-01
• Last updated: 2026-03-09

Locations

51 sites across 8 countries: United States, Australia, France, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study