Zanidatamab Oncology Clinical Trials

Jazz Pharmaceuticals’ investigational medicine, zanidatamab, is being developed in multiple clinical trials as a potential targeted treatment option for patients with solid tumors that express the HER2 protein which is found in many cancer types. HER2 plays an important role in cell growth and survival, but many cancers, including biliary tract, gastric, breast and colorectal can overexpress this protein, leading to uncontrolled cell growth.

Zanidatamab works by blocking the HER2 signal in the body while removing the HER2 protein from the cell surface. HER2 signaling tells cancer cells to survive, grow, and multiply. So, blocking this signal and removing HER2 protein from cancer cells may treat tumors. In addition, we are studying zanidatamab’s potential to activate the immune system to attack tumors, which may also help to treat the cancer.

HER2 Cell
Zanidatamab is an investigational, HER2-targeted bispecific antibody that can simultaneously bind two non-overlapping epitopes (or antigens) of HER2. This unique design and increased binding is believed to result in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity. It is also thought that bispecific antibodies may help overcome challenges associated with co-administration of drugs, such as dose-limiting toxicities and drug-drug interactions, by circumventing the need to deliver two separate therapies.

Jazz is conducting clinical trials for zanidatamab in the following disease states: as a single agent treatment for refractory biliary tract cancer (BTC) and in conjunction with current standard of care treatment for BTC; in combination with standard of care chemotherapy for gastroesophageal adenocarcinoma (GEA); and for refractory breast cancer. The company is also exploring additional clinical studies of zanidatamab in other indications.

Developing novel ways to target specific proteins like HER2 may lead to improved standards of care in oncology, which is particularly needed for difficult-to-treat cancers. Due to their aggressive natures, these cancers present challenges for treatment and typically have poor prognoses for patients.
Zanidatamab

To learn more about the zanidatamab clinical trials,
please review details on each clinical trial below:

HERIZON BTC-302

Biliary Tract Cancer

The HERIZON-BTC-302 Phase 3 trial of zanidatamab in advanced or metastatic HER2-positive BTC is now open for enrollment. In this trial, zanidatamab is not being studied alone, but in combination with standard treatments for biliary tract cancer.

HERIZON BTC-302

The global, open-label, randomized trial will evaluate the efficacy and safety of zanidatamab in combination with standard-of-care therapy (chemotherapy and immunotherapy (PD-1)) against standard-of-care therapy alone. Please click on this link (NCT06282575) to learn more about the study and to locate participating clinical sites.

HERIZON GEA-301

Metastatic Breast Cancer

The EMPOWHER-303 trial is a global, Phase 3 study evaluating the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy compared to trastuzumab in combination with physician’s choice chemotherapy for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment.

This study is currently enrolling. For more information about this study and participating sites, visit clinicaltrials.gov (and search “NCT06435429” or click https://clinicaltrials.gov/study/NCT06435429), or email clinicaltrialdisclosure@jazzpharma.com.

HERIZON GEA-301