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Active, Not Recruiting

NCT Number: NCT06533059

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

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Adnexal Diseases Advanced Solid Tumor Breast Cancer Breast Diseases Breast Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Randwick, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALTA2618

Drug

Oral ALTA2618 tablets will be administered at protocol-defined dose

Primary outcomes

  1. Adverse Events

    Time frame: Up to 39 months

    Number of participants that experience treatment-emergent adverse events (TEAEs).

  2. Dose Limiting Toxicities

    Time frame: 21 days

    Number of participants with Dose Limiting Toxicities (DLTs).

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose

    Cmax

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose

    Tmax

  3. Area Under Plasma Concentration Time Curve During the Dosing Interval (AUCt)

    Time frame: Cycle 1 (each cycle is 21 days) Day 1 (or Lead-in) and Day 8: Predose and up to 24 hours postdose

    AUCt

  4. Terminal Half-Life (t1/2)

    Time frame: Cycle 1 (each cycle is 21 days) Lead-in phase: Predose and up to 72 hours postdose

    t1/2

  5. Overall Response Rate (ORR)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  6. Duration of Response (DOR)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  7. Progression-Free Survival (PFS)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

  8. Overall Survival (OS)

    Time frame: Up to 39 months

    Assess per RECIST 1.1

Sponsors and collaborators

Lead sponsor

Alterome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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