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AUY922/m2

Phase 1

Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment117

FDA Designations

No designations recorded

Clinical trial landscape

AUY922/m2 · 1 trial · 2 indications

Phase 1 1
NCT00526045Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer PatientsBreast Cancer
COMPLETED117 Analytics
PHASE1COMPLETED
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The safe dose of AUY922 when administered once a week
54 weeks (MTD determination)

Secondary Endpoints

Efficacy of AUY922 administered once a week
Baseline, and every 2 cycles (time to document tumor progression)
Pharmacokinetics of AUY922 and Pharmacodynamics by PET response, blood and tumor biomarkers at baseline and post-AUY922
Baseline and every 2 cycles
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EscalationEXPERIMENTAL -
HER2 PositiveEXPERIMENTAL -
ER+ breast cancerEXPERIMENTAL -

Interventions

NameTypeDescription
AUY922 2 mg/m2DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists. Breast cancer phase II expansion arms only: 1. Females patients ...

Countries:United StatesNetherlandsSwitzerlandUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about AUY922/m2

What is AUY922 used for?

AUY922 is an investigational small molecule being studied for multiple oncology indications, including advanced HER2-positive breast cancer, advanced solid tumors, advanced gastric cancer, non-small-cell lung cancer, and relapsed or refractory multiple myeloma. It is also being evaluated in stomach and esophageal neoplasms, metastatic gastric cancer with mutated PI3KCA protein, and HER2-overexpressing tumors.

What does AUY922 target?

AUY922 is an HSP90 inhibitor, a class of drugs that target the heat shock protein 90 chaperone. By inhibiting HSP90, AUY922 disrupts the folding and stability of client proteins involved in cancer growth, including HER2 and PI3KCA. This mechanism is being studied across several HER2-positive and PI3KCA-mutated tumor types.

Who makes AUY922?

AUY922 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. Novartis is conducting clinical trials of AUY922 across multiple oncology indications, including breast cancer, gastric cancer, and solid tumors.

What phase is AUY922 in?

AUY922 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials, including a Phase 2 study in advanced gastric cancer. However, AUY922 is still investigational and has not been approved by regulatory authorities. It remains in active clinical development for several oncology indications.

What clinical trials is AUY922 in?

AUY922 has been studied in several completed clinical trials, including NCT00526045, a Phase 1-2 study in advanced solid malignancies and breast cancer; NCT01084330, a Phase 2 trial in advanced gastric cancer; NCT01271920, a Phase 1 combination study with trastuzumab in HER2-positive breast cancer; and NCT01613950, a Phase 1 study combining AUY922 with BYL719 in gastric cancer.

Is AUY922 the same as luminespib?

AUY922 is also known by the generic name luminespib, though this alternative name is not provided in the available data. The drug is being developed by Novartis under the code AUY922. Readers searching for luminespib should note that it refers to the same investigational HSP90 inhibitor.