NCT06736704PHASE1, PHASE2Recruiting

SNV4818 in Participants With Advanced Solid Tumors

Pikavation Therapeutics, Inc.

Start Date

2/20/2025

Completion Date

6/1/2027

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

Age Range: 18 years to No maximum

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 clinically relevant tumor biomarkers in blood. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 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

Interventions

DRUG

SNV4818

DRUG

Fulvestrant

DRUG

Palbociclib

Interested in This Trial?

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Conditions

Advanced Solid Tumors

Locations

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

Los Angeles, California 90025

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Thomas Jefferson University-Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania 19107

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas 77030

United States

Chris O'Brien Lifehouse

Camperdown, New South Wales 2050

Australia

Scientia Clinical Research

Randwick, New South Wales 2031

Australia

Monash Health

Clayton, Victoria 3168

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

Linear Clinical Research

Nedlands, Western Australia 6009

Australia

The Ottawa Hospital Cancer Centre

Ottawa, Ontario K1H 8L6

Canada

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada