Zanidatamab
Clinical Trials Overview
6 trials found
About Zanidatamab
Zanidatamab is a bispecific antibody that targets HER2-positive colorectal cancers by binding to two distinct epitopes on the HER2 receptor simultaneously. This dual-targeting approach is designed to enhance HER2 blockade and overcome resistance mechanisms that may limit single-epitope HER2 inhibitors. The drug is specifically indicated for colorectal cancer patients whose tumors harbor HER2 gene alterations or overexpression, representing a targeted approach for this molecularly-defined subset of CRC patients.
Category
Immunotherapy
Brand Name
Not yet branded
Mechanism
Zanidatamab functions as a bispecific monoclonal antibody that simultaneously binds to two different extracellular domains (ECD2 and ECD4) of the HER2 receptor. This dual binding blocks HER2 signaling pathways while promoting antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). The bispecific design aims to provide more complete HER2 inhibition compared to monospecific antibodies and may help overcome tumor resistance mechanisms.
Efficacy Data by Mutation
Response rates and survival outcomes by patient molecular profile
HER2 IHC 2+/3+
2B
35%
ORR
6m
PFS
n=40
Sample
HER2 HER2+ (IHC 3+ or IHC 2+/FISH+)
3
91%
ORR
n=11
Sample
6
Total Trials
4
Recruiting
0
Active
0
Completed
1,191
Total Enrollment
10
Countries
Research trend for Zanidatamab
Number of trials started per year
Research remains steady, with 3 trials in 2026.
Active sites for Zanidatamab
Recruiting sites
10 countries
Phase:
NCT07405476
Phase 2
Recruiting
38 patients
Medications:
Zanidatamab
This phase II trial studies how well giving zanidatamab before surgery (neoadjuvant) works in treating patients with colon and rectal cancer that is human epidermal growth factor receptor 2 positive (HER2+ve) who are planned for curative intent treat...
United States
NCT07192068
Phase 2
Recruiting
105 patients
Medications:
Zanidatamab
Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, ut...
France
NCT06695845
Phase 2
Recruiting
200 patients
Medications:
Zanidatamab
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpress...
United States, South Korea, Spain
NCT06324357
Phase 1
Recruiting
768 patients
Medications:
5-Fluorouracil
Capecitabine
Leucovorin
Oxaliplatin
Trastuzumab
Trastuzumab deruxtecan
Zanidatamab
Zongertinib
This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not succe...
United States, Belgium, China, France, Germany, Italy, Japan, South Korea, Spain, United Kingdom
NCT07631871
Phase 2
Not yet recruiting
10 patients
Medications:
Zanidatamab
The goal of this clinical trial is to learn if Zanidatamab can treat HER2-positive advanced tumors in adults. The main question it aims to answer is: What is the objective response rate of Zanidatamab in adult patients with HER-2 positive advanced so...
NCT07243938
Phase 2
Not yet recruiting
70 patients
This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive locally advanced or metast...