Recruiting
Phase 1
Phase 2

SNV4818

Sponsor:

Pikavation Therapeutics, Inc.

Code:

NCT06736704

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SNV4818

Fulvestrant

Palbociclib

Study Details

Brief 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.

Conditions

Advanced Solid Tumors

Study ID

NCT06736704

Start date

Feb 20, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

320 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SNV4818 Monotherapy

Participants will receive oral, daily doses of SNV4818 as a single agent as part of either dose escalation or dose expansion cohorts. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

experimental: SNV4818+Fulvestrant Combination

Participants will receive oral, daily doses of SNV4818 in combination with a standard dose of Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

experimental: SNV4818+Palbociclib+Fulvestrant Combination

Participants will receive oral, daily doses of SNV4818 in combination with a standard doses of Palbociclib and Fulvestrant as part of either dose escalation or dose expansion cohorts.. The SNV4818 dose level participants receive will depend upon the study part to which they are assigned. Dose escalation participants will be assigned to small cohorts of ascending SNV4818 dose levels. Dose expansion participants will receive one of the SNV4818 dose levels recommended for further evaluation.

Interventions

SNV4818

SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.

Fulvestrant

Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)

Palbociclib

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

Primary outcome measure

  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: First 28 days of study treatment ]
  • Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first SNV4818 dose through approximately 30 days following the last SNV4818 dose ]

Central Contacts and Locations

Central contacts

Robert Casper

443-764-9527rcasper@synnovationtx.com

Locations

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

Recruiting

Los Angeles, California, United States, 90025

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Thomas Jefferson University-Sidney Kimmel Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

Pikavation Therapeutics, Inc.

Last update posted

Mar 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pikavation Therapeutics, Inc. on 2026-03-13.