SNV4818 in Participants With Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SNV4818; Drug: Fulvestrant; Drug: Palbociclib

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Robert Casper; Phone Number: 443-764-9527; Email: rcasper@synnovationtx.com

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Recruiting
      • Chris O'Brien Lifehouse
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Scientia Clinical Research
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Recruiting
      • Monash Health
    • Melbourne, Victoria, Australia, 3000
      • Recruiting
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Linear Clinical Research
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network, Princess Margaret Cancer Centre
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University-Sidney Kimmel Cancer Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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.	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; Drug: 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; Other Names: Ibrance

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration of SNV4818	Cmax	After 4 weeks (1 cycle) of study treatment
Time to reach the maximum observed plasma concentration of SNV4818	Tmax	After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818	AUC0-t	After 4 weeks (1 cycle) of study treatment
Half-life of SNV4818	t1/2	After 4 weeks (1 cycle) of study treatment
Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity	AUC0-infinity	After 1 day of study treatment
Apparent oral clearance of SNV4818	CL/F	After 4 weeks (1 cycle) of study treatment
Apparent volume of distribution of SNV4818	Vz/F	After 4 weeks (1 cycle) of study treatment
Overall response rate (ORR)	The proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), based on RECIST 1.1 criteria	After 8 weeks on study treatment
Disease control rate (DCR)	The proportion of participants who have a best overall response (BOR) of stable disease (SD) or better	After 8 weeks on study treatment
Duration of response (DOR)	The time interval between an assessment of partial response (PR) or better and disease progression or death due to any cause.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Pikavation Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant; palbociclib
• Other Study ID Numbers: SNV4818-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No