RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2, Open-Label Dose Escalation and Expansion Study of SNV4818 as Monotherapy or in Combination With Other Anticancer Agents in Participants With Advanced Solid Tumors

NCT ID: NCT06736704Sponsor: Pikavation Therapeutics, Inc.Last updated: 2026-03-13

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.

Arms & interventions

DrugSNV4818
SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
DrugFulvestrant
Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
DrugPalbociclib
Palbociclib tablets will be administered by mouth on days 1-21 of a 28 day cycle. The Palbociclib starting dose will be 125 mg once-daily

Outcome measures

Primary

Incidence of dose limiting toxicities (DLTs)
-Number of participants experiencing protocol-defined DLTs (Part 1A and 2A only)
Time frame: First 28 days of study treatment
Treatment Emergent Adverse Events (TEAEs)
Incidence and frequency of TEAEs
Time frame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose

Secondary

Maximum observed plasma concentration of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Time to reach the maximum observed plasma concentration of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Half-life of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity
Time frame: After 1 day of study treatment
Apparent oral clearance of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Apparent volume of distribution of SNV4818
Time frame: After 4 weeks (1 cycle) of study treatment
Overall response rate (ORR)
Time frame: After 8 weeks on study treatment
Disease control rate (DCR)
Time frame: After 8 weeks on study treatment
Duration of response (DOR)
Time frame: Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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

Study locations (5)

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

Los Angeles, California, 90025

Recruiting

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting

Thomas Jefferson University-Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030

Recruiting