NCT06736704

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for phase_1

Timeline
10mo left

Started Feb 2025

Typical duration for phase_1

Geographic Reach
3 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Feb 2025Jun 2027

First Submitted

Initial submission to the registry

December 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 20, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

December 12, 2024

Last Update Submit

March 12, 2026

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Maximum observed plasma concentration of SNV4818

    After 4 weeks (1 cycle) of study treatment

  • Time to reach the maximum observed plasma concentration of SNV4818

    After 4 weeks (1 cycle) of study treatment

  • Area Under Plasma Concentration (AUC) Time Curve of SNV4818

    After 4 weeks (1 cycle) of study treatment

  • Half-life of SNV4818

    After 4 weeks (1 cycle) of study treatment

  • Area Under Plasma Concentration (AUC) Time Curve of SNV4818 extrapolated to infinity

    After 1 day of study treatment

  • +5 more secondary outcomes

Study Arms (3)

SNV4818 Monotherapy

EXPERIMENTAL

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+Fulvestrant Combination

EXPERIMENTAL

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: SNV4818Drug: Fulvestrant

SNV4818+Palbociclib+Fulvestrant Combination

EXPERIMENTAL

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: SNV4818Drug: FulvestrantDrug: Palbociclib

Interventions

SNV4818DRUG

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

SNV4818 MonotherapySNV4818+Fulvestrant CombinationSNV4818+Palbociclib+Fulvestrant Combination
FulvestrantDRUG

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

Also known as: Faslodex
SNV4818+Fulvestrant CombinationSNV4818+Palbociclib+Fulvestrant Combination
PalbociclibDRUG

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

Also known as: Ibrance
SNV4818+Palbociclib+Fulvestrant Combination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

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

Los Angeles, California, 90025, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Thomas Jefferson University-Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

RECRUITING

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

Fulvestrantpalbociclib

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Robert Casper

CONTACT

443-764-9527rcasper@synnovationtx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 17, 2024

Study Start

February 20, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 13, 2026

Record last verified: 2026-02

Locations

AU(5)CA(2)US(5)