Recent Updates
Recently added Catalysts

BGT226

Phase 1

Solid Tumors | Small molecule | Oncology |Novartis AG|Trials Updated: Dec 17, 2020

BGT226 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jan 2008

BGT226 target and mechanism

Molecular targetPIK3R1, PIK3CB, PIK3CG, PIK3CA, PIK3R2, PIK3CD
Target classInhibitor
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

BGT226 clinical trials

BGT226 · 1 trial · 3 indications

Phase 1 1
NCT00600275A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast CancerSolid Tumors
COMPLETED57 Analytics
PHASE1COMPLETED
A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)
throughout the study

Secondary Endpoints

Pharmacodynamics Changes in biological markers indicative of the inhibitory effect of BGT226. Changes in cellular physiology as assessed by Positron Emission Tomography (PET) imaging
throughout the study
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BGT226EXPERIMENTAL -

Interventions

NameTypeDescription
BGT226DRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion criteria: All patients * Histologically-confirmed, advanced solid tumors * Progressive, recurrent unresectable disease Phase II expansion part (advanced breast cancer) * Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression st...

Countries:United StatesCanadaSpain
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about BGT226

What is BGT226?

BGT226 is an investigational small molecule drug developed by Novartis AG for the treatment of advanced solid tumors. It was studied in a Phase 1/2 clinical trial that enrolled 57 adult patients with advanced solid malignancies, including advanced breast cancer and Cowden syndrome. It is not an approved therapy and remains in clinical development.

What does BGT226 target?

BGT226 is a phosphatidylinositol 3-kinase (PI3K) inhibitor. It targets the PIK3CA, PIK3CB, PIK3CD, and PIK3CG catalytic subunits as well as the PIK3R1 and PIK3R2 regulatory subunits. By inhibiting these PI3K proteins, BGT226 interferes with signaling pathways involved in tumor cell growth and survival.

Who makes BGT226?

BGT226 is developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis sponsored the Phase 1/2 study of the compound in patients with advanced solid malignancies.

What phase is BGT226 in?

BGT226 is in Phase 1 development. It has been evaluated in a single Phase 1/2 clinical trial in adult patients with advanced solid malignancies. The trial is completed, and no active trials of BGT226 are currently listed. The drug is investigational and has not been approved by the FDA.

What clinical trials is BGT226 in?

BGT226 was studied in clinical trial NCT00600275, titled a Phase I/II study of BGT226 in adult patients with advanced solid malignancies, including patients with advanced breast cancer. The trial enrolled 57 patients across the United States, Canada, and Spain, and it is now completed.

What is BGT226 used for in solid tumors?

BGT226 was studied for the treatment of advanced solid tumors, including advanced breast cancer and Cowden syndrome, in adult patients aged 18 years and older. The Phase 1/2 trial NCT00600275 evaluated the drug in this patient population and has been completed.