SNV4818 in Participants With Advanced Solid Tumors

Last updated: March 12, 2026
Sponsor: Pikavation Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

Palbociclib

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: 320
Treatment Group(s): 3
Primary Treatment: Palbociclib
Phase: 1/2
Study Start date:
February 20, 2025
Estimated Completion Date:
June 30, 2027

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

  • Chris O'Brien Lifehouse

    Camperdown 2172563, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Scientia Clinical Research

    Randwick 2208285, New South Wales 2155400 2031
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Monash Health

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • 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

  • The Ottawa Hospital Cancer Centre

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • University Health Network, Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Site Not Available

  • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Thomas Jefferson University-Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Thomas Jefferson University-Sidney Kimmel Cancer Center

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

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

    Houston, Texas 77030
    United States

    Active - Recruiting

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

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.