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SNV4818 for Advanced Solid Tumors with PIK3CA Mutation

This study is testing a new oral medication called SNV4818 for people with advanced solid tumors that have a specific genetic change called a PIK3CA mutation. Researchers want to find the safest and most effective dose of SNV4818. Some participants may also receive Fulvestrant (an injection) or Palbociclib (an oral tablet). The main goals are to see how safe SNV4818 is and what side effects it might cause. You may be able to join if your cancer has progressed despite other treatments and you meet other health criteria. The study plans to enroll 320 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 320 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects from the first dose of SNV4818 through about 30 days after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06736704

SNV4818 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Pikavation Therapeutics, Inc.
~320 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:SNV4818FulvestrantPalbociclib

At a glance

Recruiting sites
12 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs)
Measured over First 28 days of study treatment
+1 more outcome measured

Conditions

Advanced Solid Tumors

Explore related trials

Solid NeoplasmPIK3CA Gene

Where it's being run

12 sites across 9 states
New South Wales2
Victoria2
Ontario2
California1
Massachusetts1
Pennsylvania1
Tennessee1
Texas1

Who to contact

Robert Casper
[email protected]
443-764-9527
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of dose limiting toxicities (DLTs)First 28 days of study treatment

    -Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)

  • Treatment Emergent Adverse Events (TEAEs)From first SNV4818 dose through approximately 30 days following the last SNV4818 dose

    Incidence and frequency of TEAEs