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Brodalumab

Phase 1

Breast Cancer | Small molecule | Oncology |Bausch + Lomb Corporation|Last Updated: May 14, 2025

Target and mechanism

Molecular targetIL17RA
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11

FDA Designations

No designations recorded

Clinical trial landscape

Brodalumab · 1 trial · 18 indications

Phase 1 1
NCT06673329Brodalumab in the Treatment of Immune-Related Adverse EventsBreast Cancer
RECRUITING11 Analytics
PHASE1RECRUITING
Brodalumab in the Treatment of Immune-Related Adverse Events
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Adverse Events
Up to 36 weeks

The number of adverse events of each grade that occur and the number of adverse events attributed to brodalumab, as per the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5).

Percentage of primary Immune-Related Adverse Event (irAE) severity decreased
24 weeks

The percentage of patients whose primary irAE severity decreased by \>1 grade per CTCAE criteria from study completion to treatment discontinuation.

Secondary Endpoints

Percentage net decrease in the average steroid dose required for irAE management
Up to 36 weeks
Proportion of Patients Successfully Tapered Off Steroids
Up to 36 weeks
Mean Time to Complete Resolution of irAE Symptoms
Up to 36 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
brodalumab to treat irAEs in patient with solid tumorsEXPERIMENTALBrodalumab 210 mg subcutaneous injection on weeks 0, 1, 2 followed by administration every 2 weeks until week 24

Interventions

NameTypeDescription
BrodalumabDRUGBrodalumab 210 mg subcutaneous injection
CT scanRADIATIONCT scans within 4 weeks of starting brodalumab and every 3 months during the study for tumor assessment
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ability to provide written informed consent by subject or guardian * Individuals \>18 years of age * Diagnosis of an irAE clinically suspected to be IL-17 mediated * Intent-to-treat or prior treatment with systemic steroids for irAE management * Histology-proven primary advanc...

Countries:United States
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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 Brodalumab

What is Brodalumab used for in breast cancer?

Brodalumab is being studied for the treatment of immune-related adverse events in patients with breast cancer and other solid tumors. It is in Phase 1 clinical development as an investigational therapy. The drug is being evaluated in a single-arm, uncontrolled trial that is currently recruiting participants.

What does Brodalumab target?

Brodalumab is a monoclonal antibody (mab) that targets the interleukin-17 receptor. By blocking this receptor, it is intended to modulate the immune response. In the context of the ongoing trial, it is being investigated for its potential to manage immune-related adverse events in cancer patients.

Who makes Brodalumab?

Brodalumab is being developed by Bausch + Lomb Corporation, which trades under the ticker symbol BLCO. The company is conducting a Phase 1 clinical trial of the drug for the treatment of immune-related adverse events in patients with various solid tumors, including breast cancer.

What phase is Brodalumab in?

Brodalumab is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients and is designed to evaluate the drug's safety and efficacy in treating immune-related adverse events.

What clinical trials is Brodalumab in?

Brodalumab is being evaluated in a Phase 1 clinical trial with the identifier NCT06673329. The trial, titled 'Brodalumab in the Treatment of Immune-Related Adverse Events,' is recruiting participants in the United States. It is an uncontrolled, open-label study enrolling approximately 11 patients with various solid tumors.

Is Brodalumab the same as other drugs?

Brodalumab is a distinct monoclonal antibody and is not known to be the same as other drugs. It is being investigated for its potential role in managing immune-related adverse events in oncology. The drug is in Phase 1 development and has not been approved for any indication.