Zanidatamab
- Generic Name
- Zanidatamab
- Drug Type
- Biotech
- CAS Number
- 2169946-15-8
- Unique Ingredient Identifier
- Z20OC92TDI
- Background
According to Zymeworks, "ZW25 is a bispecific antibody that can simultaneously bind two non-overlapping epitopes, known as biparatopic binding, of HER2 resulting in dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function. These combined mechanisms of action have led to significant anti-tumor activity in preclinical models of breast and gastric cancers."
A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors
- Conditions
- Breast CancerGastric CancerEsophageal CancerGastroesophageal CancerColorectal CancerEndometrial CancerNon-small Cell Lung CancerOvarian CancerUrothelial CarcinomaSalivary Gland Cancer
- Interventions
- First Posted Date
- 2024-11-19
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 200
- Registration Number
- NCT06695845
- Locations
- 🇺🇸
Arizona Oncology Associates, PC - NAHOA, Prescott, Arizona, United States
🇺🇸Rocky Mountain Cancer Center, Littleton, Colorado, United States
🇺🇸Florida Cancer Specialists - South, Fort Myers, Florida, United States
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
- Conditions
- Metastatic HER2-positive Breast Cancer
- Interventions
- First Posted Date
- 2024-05-30
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 550
- Registration Number
- NCT06435429
- Locations
- 🇨🇦
The Ottawa Hospital Cancer Centre, Ottawa, Canada
🇺🇸Arizona Oncology Tucson - Wilmot, Tucson, Arizona, United States
🇺🇸University of Arizona Cancer Center, Tucson, Arizona, United States
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
- Conditions
- Biliary Tract Cancer
- Interventions
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 286
- Registration Number
- NCT06282575
- Locations
- 🇵🇹
Champalimaud Clinical Center, Lisboa, Portugal
🇵🇹Instituto Português de Oncologia Do Porto Francisco Gentil, EPE, Porto, Portugal
🇷🇴Centrul de Oncologie Euroclinic SRL, Iasi, Romania
Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Postive Advanced Gastroesophageal Adenocarcinoma
- Conditions
- Gastroesophageal Adenocarcinoma
- Interventions
- First Posted Date
- 2023-09-21
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 168
- Registration Number
- NCT06043427
- Locations
- 🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇨🇦BCCA - Vancouver, Vancouver, British Columbia, Canada
PRE-I-SPY Phase I/Ib Oncology Platform Program
- Conditions
- Metastatic Breast CancerMetastaticHormone Receptor-positive Breast CancerHormone Receptor Negative Breast CarcinomaHER2 Low Breast CancerHER2 Low Breast CarcinomaHER2-positive Breast CancerMetastatic CancerHER2-negative Breast CancerSolid Tumor, Adult
- Interventions
- First Posted Date
- 2023-05-22
- Last Posted Date
- 2025-04-04
- Lead Sponsor
- QuantumLeap Healthcare Collaborative
- Target Recruit Count
- 124
- Registration Number
- NCT05868226
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
Personalized Medicine for Advanced Biliary Cancer Patients
- Conditions
- Biliary Tract Neoplasms
- Interventions
- First Posted Date
- 2022-11-14
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 800
- Registration Number
- NCT05615818
- Locations
- 🇫🇷
APHP - Hôpital Paul Brousse, Villejuif, France
🇫🇷Gustave Roussy, Villejuif, France
🇫🇷APHP - Hôpital Cochin, Paris, France
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
- Conditions
- Gastric NeoplasmsGastroesophageal AdenocarcinomaEsophageal Adenocarcinoma
- Interventions
- First Posted Date
- 2021-12-09
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 920
- Registration Number
- NCT05152147
- Locations
- 🇨🇳
The First Affiliated Hospital of Fujian Medical University, Fuzhou, China
🇨🇳Guangdong Provincial People's Hospital, Guangzhou, China
🇨🇳The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)
- Conditions
- Breast CancerHER2-positive
- Interventions
- First Posted Date
- 2021-09-05
- Last Posted Date
- 2025-01-09
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 20
- Registration Number
- NCT05035836
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer
- Conditions
- HER2-expressing Cancers
- Interventions
- First Posted Date
- 2021-08-30
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 52
- Registration Number
- NCT05027139
- Locations
- 🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Astera Cancer Care, East Brunswick, New Jersey, United States
🇺🇸UC San Diego - Moores Cancer Center, La Jolla, California, United States
An Expanded Access Treatment Protocol of Zanidatamab (ZW25) in Patients With HER2-Positive Advanced Biliary Tract Cancer
- Conditions
- HER2-Positive Advanced Biliary Tract Cancer
- First Posted Date
- 2020-10-08
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Jazz Pharmaceuticals
- Registration Number
- NCT04578444
- Locations
- 🇺🇸
NoCo Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸TOI Clinical Research, Cerritos, California, United States
🇺🇸Salinas Valley Memorial Healthcare System, Salinas, California, United States
Drug Development Updates
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