Zanidatamab Oncology Clinical Trials
Jazz Pharmaceuticals’ is investigating zanidatamab 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 is believed to work 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.
Zanidatamab is a 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 HER2-positive cancers in the following areas: in conjunction with current standard of care treatment for first-line biliary tract cancer (BTC); in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA); in combination with physician choice chemotherapy in previously treated metastatic breast cancer; and as a single-agent therapy in multiple HER2-positive cancers. The company is also exploring additional clinical studies of zanidatamab in other indications.
To learn more about the zanidatamab clinical trials,
please review details on each clinical trial below:
Biliary Tract Cancer
The HERIZON-BTC-302 trial is a Phase 3, global, open-label, randomized study evaluating the efficacy and safety of zanidatamab with standard-of-care therapy (chemotherapy ± immunotherapy (PD-1/L1)) against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer.
This study is currently enrolling. Please click on this link (NCT06282575) to learn more about the study and to locate participating clinical sites. For more information about this study and participating sites, please visit biliarytractcancerstudy.com.
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.
Pan Tumor Cancers
The DiscovHER PAN-206 trial is a global, open-label Phase 2 trial evaluating the efficacy and safety of zanidatamab in adult participants with locally advanced or metastatic HER2-positive solid tumors (except biliary tract cancer [BTC]) who have progressed following at least 1 prior systemic treatment for advanced or metastatic disease (Cohort 1). This trial is open to any HER2-overexpressing (IHC 3+) solid tumor (except BTC), including, but not limited to, breast, gastric, esophageal, gastroesophageal, colorectal, endometrial, non-small cell lung, ovarian, urothelial, salivary, and pancreatic cancer. Enrolled participants with breast cancer and gastroesophageal adenocarcinoma (GEA) must have received a prior therapy called trastuzumab deruxtecan (T-DXd) and may have received other prior HER2-targeted therapy. For all other cancers, prior HER2-targeted therapy is not permitted prior to enrollment into the trial.
The DiscovHER PAN-206 trial is currently enrolling. For more information about this trial and participating sites, visit clinicaltrials.gov (and search “NCT06695845”) or click here, or email clinicaltrialdisclosure@jazzpharma.com.