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

Study Identifier:
2618-001
CT.gov Identifier:
NCT06533059
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2024-515391-12-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

To evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of ALTA2618 in patients with advanced unresectable or metastatic solid tumor

To evaluate ALTA2618 in patients with previously treated, locally advanced, unresectable or metastatic solid tumors with AKT1 E17K

mutation.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Unspecified Cancer
  • Breast Cancers
  • Endometrial
  • Metastatic Cancer
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ALTA2618
    • Read More
  • Drug: Drug: ALTA2618
  • Drug: SABCS 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Breast Cancers
    Endometrial
    Metastatic Cancer
    Solid Tumor
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Unspecified Cancer
    Breast Cancers
    Endometrial
    Metastatic Cancer
    Solid Tumor