Recent Updates
Recently added Catalysts

Zanidatamab

Phase 1

Breast Cancer | Monoclonal antibody | Oncology |BeOne Medicines Ltd.|Last Updated: Dec 6, 2024

Target and mechanism

Molecular targetERBB2
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

Zanidatamab · 1 trial · 3 indications

Phase 1 1
NCT04276493Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without TislelizumabBreast Cancer
COMPLETED71 Analytics
PHASE1COMPLETED
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants experiencing Adverse Events (AEs)
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
Number of Participants experiencing Serious Adverse Events (SAEs) as assessed by the investigator.
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months
Objective response rate (ORR)
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months

Defined as the percentage of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Secondary Endpoints

Duration of response (DOR)
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Time to response (TTR)
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Progression-free survival (PFS)
From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1- Zanidatamab + DocetaxelEXPERIMENTALZanidatamab intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer
Cohort 2- Zanidatamab + Tiselizumab + ChemotherapyEXPERIMENTALZanidatamab intravenous (IV) infusion followed by tislelizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma

Interventions

NameTypeDescription
ZanidatamabBIOLOGICALAdministered intravenously
DocetaxelDRUGAdministered intravenously
TislelizumabBIOLOGICALAdministered intravenously
CapecitabineDRUGAdministered orally
OxaliplatinDRUGAdministered intravenously
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Key Inclusion Criteria: 1. Disease diagnosis and prior treatment: 1. Cohort 1 (the first-line breast cancer treatment cohort): * Female participants with histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the breast and can...

Countries:ChinaSouth KoreaTaiwan
Unlock Eligibility Criteria

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
Unlock Competitive Intelligence

Frequently asked questions about Zanidatamab

What is Zanidatamab used for in Breast Cancer?

Zanidatamab is an investigational monoclonal antibody being studied for the treatment of breast cancer. It is also being evaluated in gastric cancer and gastroesophageal junction cancer. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Zanidatamab target?

Zanidatamab is a bispecific antibody that targets HER2, a protein that can promote cancer cell growth. By binding to HER2, the antibody is designed to interfere with cancer cell signaling. This mechanism is being studied in HER2-positive cancers, including breast cancer.

Who makes Zanidatamab?

Zanidatamab is being developed by BeOne Medicines Ltd., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol ONC. BeOne Medicines is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is Zanidatamab in?

Zanidatamab is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory agencies such as the FDA. The drug is being studied in clinical trials to assess its safety, tolerability, and potential efficacy in treating certain cancers.

What clinical trials is Zanidatamab in?

Zanidatamab is being studied in clinical trial NCT04276493, titled 'Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab.' This Phase 1 trial has been completed and enrolled 71 participants with breast cancer, gastric cancer, or gastroesophageal junction cancer.

Is Zanidatamab the same as ZW25?

Yes, Zanidatamab is also known as ZW25. The clinical trial NCT04276493 refers to the drug as 'Zanidatamab (ZW25),' confirming that these names refer to the same investigational bispecific antibody. This alternative name may appear in scientific literature and clinical trial registries.