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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: SNV4818
    SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
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.
  • Drug: SNV4818
    SNV4818 is a tablet taken orally. Dose and frequency are dependent upon treatment arm.
  • Drug: Fulvestrant
    Fulvestrant is administered via an intramuscular injection. It will be given at a dose of 500 mg (2-250 mg/5 mL injections)
    Other names:
    • Faslodex

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Pikavation Therapeutics, Inc.

Study Contact

Robert Casper
443-764-9527
rcasper@synnovationtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.