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

Phase 1

Recruiting

• Conditions: Cancer; Breast Cancer; Endometrial Cancer; Metastatic Cancer; Advanced Solid Tumor
• Interventions: Drug: ALTA2618

• Registration Number: NCT06533059
• Lead Sponsor: Alterome Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2024-07-25
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Study Start: 2024-08-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-12-29
• Study Completion: 2027-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALTA2618	ALTA2618	ALTA2618 will be administered continuously at a protocol-defined dose based on cohort assignment

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 39 months	Number of participants that experience treatment-emergent adverse events (TEAEs).
Dose Limiting Toxicities	21 days	Number of participants with Dose Limiting Toxicities (DLTs).

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 39 months	Assess per RECIST 1.1
Terminal Half-Life (t1/2)	Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose	t1/2
Overall Response Rate (ORR)	Up to 39 months	Assess per RECIST 1.1
Duration of Response (DOR)	Up to 39 months	Assess per RECIST 1.1
Progression-Free Survival (PFS)	Up to 39 months	Assess per RECIST 1.1
Maximum Observed Plasma Concentration (Cmax)	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose	Cmax
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose	Tmax
Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)	Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose	AUCt

Trial Locations

Locations (2)

Research Site; 🇨🇳 Taipei, Taiwan

Research Site #2; 🇺🇸 San Antonio, Texas, United States