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Zenocutuzumab

Phase 2

Breast Cancer Metastatic | Small molecule | Oncology |Merus N.V.|Last Updated: Mar 7, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment105

FDA Designations

BREAKTHROUGH_THERAPY

Clinical trial landscape

Zenocutuzumab · 1 trial · 1 indication

Phase 2 1
NCT03321981MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.Breast Cancer Metastatic
COMPLETED105 Analytics
PHASE2COMPLETED
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
Breast Cancer MetastaticUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Benefit Rate at 24 Weeks
24 weeks

Clinical benefit rate (CBR) at 24 weeks per investigator assessment. CBR is the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) lasting 24 weeks.

Secondary Endpoints

Progression Free Survival (PFS) Per Investigator Assessment
Baseline, every 6 weeks until end of treatment, every 3 months thereafter up to 1 year after treatment (if not progressed at end of treatment)
Progression Free Survival (PFS) Per Central Review
Baseline, every 6 weeks until end of treatment, every 3 months thereafter up to 1 year after treatment (if not progressed at end of treatment)
Overall Response Rate (ORR) Per Investigator Assessment
Baseline, every 6 weeks until end of treatment, every 3 months thereafter up to 1 year after treatment (if not progressed at end of treatment)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 doubletEXPERIMENTALzenocutuzumab + trastuzumab
Cohort 1 tripletEXPERIMENTALzenocutuzumab + trastuzumab + vinorelbine
Cohort 2EXPERIMENTALzenocutuzumab + endocrine therapy

Interventions

NameTypeDescription
ZenocutuzumabDRUGfull length immunoglobulin gamma-1 (IgG1) bispecific antibody targeting Human Epidermal Growth Factor Receptor (HER)2 and HER3
TrastuzumabDRUGhumanised IgG1 monoclonal antibody
VinorelbineDRUGantineoplastic drug of vinca alkaloid family
Endocrine therapyDRUGsame endocrine therapy is administered as the last line of endocrine therapy
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites25

Inclusion Criteria 1. Signed informed consent before initiation of any study procedures. 2. Women with histologically or cytologically confirmed breast cancer with evidence of metastatic or locally advanced disease not amenable to any local therapy with curative intent: 2.1 Cohort 1 (zenocutuzu...

Countries:United StatesBelgiumFranceNetherlandsPortugalSpainUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials (matched to "Breast Cancer Metastatic")

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 Zenocutuzumab

What is Zenocutuzumab used for in Breast Cancer Metastatic?

Zenocutuzumab is an investigational drug being studied for the treatment of metastatic breast cancer. It is being evaluated in combination with other therapies, including trastuzumab and chemotherapy for HER2-positive disease, and with endocrine therapy for estrogen receptor-positive, low HER2 breast cancer.

What does Zenocutuzumab target?

Zenocutuzumab is a bispecific antibody that targets HER2 and HER3 receptors. By binding to these receptors, it is designed to block signaling pathways that can drive tumor growth in certain breast cancers.

Who makes Zenocutuzumab?

Zenocutuzumab is being developed by Merus N.V., a clinical-stage oncology company. Merus is publicly traded on the Nasdaq under the ticker symbol MRUS.

What phase is Zenocutuzumab in?

Zenocutuzumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. It has received Breakthrough Therapy designation from the FDA for its potential use in certain cancers.

What clinical trials is Zenocutuzumab in?

Zenocutuzumab has been studied in a completed Phase 2 clinical trial with the identifier NCT03321981. This trial enrolled 105 female participants aged 18 years and older with metastatic breast cancer across multiple countries, including the United States, Belgium, France, the Netherlands, Portugal, Spain, and the United Kingdom.

Is Zenocutuzumab the same as MCLA-128?

Yes, Zenocutuzumab is also known as MCLA-128. The clinical trial NCT03321981, which evaluated Zenocutuzumab in metastatic breast cancer, used the name MCLA-128 in its title.