SNV4818 in Participants With Advanced Solid Tumors

Last updated: May 12, 2025
Sponsor: Pikavation Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Fulvestrant

SNV4818

Clinical Study ID

NCT06736704
SNV4818-101
  • Ages > 18
  • All Genders

Study Summary

This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the safest and most effective one.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Advanced or metastatic solid tumor with an activating PIK3CA mutation.

  • Refractory to or intolerant of available therapies

  • Disease measurable by RECIST 1.1 criteria, or disease evaluable by clinicallyrelevant tumor biomarkers in blood.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

Exclusion Criteria:

  • Diagnosis of a primary CNS malignancy

  • Active brain metastases or carcinomatous meningitis

  • Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus

  • Inadequate organ function

  • Clinically significant ECG abnormalities, including QTcF ≥ 470 ms

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: Fulvestrant
Phase: 1
Study Start date:
February 20, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Scientia Clinical Research

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, W. Australia 6009
    Australia

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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