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SNV4818 in Participants With Advanced Solid Tumors

RECRUITINGPhase 1/2Sponsored by Pikavation Therapeutics, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorPikavation Therapeutics, Inc.
Started2025-02-20
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations4 sites
View on ClinicalTrials.gov →

NCT06736704

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Advanced Solid TumorsCancer

Locations4 sites

Massachusetts

1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114

Pennsylvania

1 site
Thomas Jefferson University-Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107

Tennessee

1 site
Sarah Cannon Research Institute
Nashville, Tennessee, 37203

Texas

1 site
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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