Clinical Trials
Clinical Trials
We have an unwavering commitment to improving care for patients with serious medical conditions through ongoing clinical development programs.
To learn more about clinical trials that are currently underway and to find out if a study is enrolling patients in your area or with your condition, please visit www.clinicaltrials.gov.
The results of certain applicable Jazz clinical trials are also available at www.clinicaltrials.gov.
As part of Jazz’s commitment to putting patients first, we are providing plain language summaries for certain clinical trials. These plain language summaries provide clinical trial results in an easy-to-understand format so all patients can obtain more information on the study results. Learn more about our study results.
Oncology
Zanidatamab
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 can be 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.
Jazz is conducting clinical trials for zanidatamab in the following disease states: in conjunction with current standard of care treatment for biliary tract cancer (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.
Learn more about zanidatamab oncology trials .
Study Evaluating Zanidatamab as First-Line Treatment in Advanced/ Metastatic HER2-Positive Gastroesophageal Adenocarcinomas (GEAs) (NCT05152147)
HERIZON-GEA-01 is a global, randomized, open-label Phase III study to evaluate and compare the efficacy and safety of zanidatamab plus chemotherapy with or without tislelizumab to the standard of care (trastuzumab plus chemotherapy) as first-line treatment for patients with advanced/metastatic human epidermal growth factor receptor 2 (HER2) positive gastroesophageal adenocarcinomas (GEAs). This study is being conducted to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. Recruitment for the study will occur at approximately 300 trial sites in more than 30 countries, and is designed to have approximately 900 adult patients with HER2-positive gastroesophageal cancer participate. For more information about this study and participating sites, visit clinicaltrials.gov (and search “NCT05152147”) or click here, or email clinicaltrialdisclosure@jazzpharma.com.
Study Evaluating Zanidatamab as First-Line Treatment in Advanced/Metastatic HER2-Positive Biliary Tract Cancer (BTC) (NCT06282575)
HERIZON-BTC-302 is a global, open-label, randomized Phase III study to evaluate the efficacy and safety of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer (BTC). The primary objective of the study is to compare the efficacy of zanidatamab and CisGem (cisplatin plus gemcitabine) with or without the addition of a programmed death protein 1/ligand 1 (PD-1/L-1) inhibitor versus CisGem with or without a PD-1/L1 inhibitor in adult participants. The study population eligible for this study are patients ≥18 years of age with locally advanced unresectable or metastatic HER2-positive BTC (gallbladder cancer or cholangiocarcinoma) and not eligible for curative resection, transplantation, or ablative therapies, and who have not had any therapy or who have just started therapy. Please click here for more information about this study and participating trial sites or email clinicaltrialdisclosure@jazzpharma.com.
Study Evaluating Zanidatamab in Metastatic HER2-Positive Breast Cancer (NCT06435429)
EmpowHER-303 is a global, open-label, randomized Phase III study to evaluate 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 being conducted to find out if zanidatamab when given with chemotherapy, is safe and works better than trastuzumab given with chemotherapy. The study population eligible for this study are patients ≥18 years of age who have received at least 2 but not more than 4 lines of HER2-directed therapies in the metastatic setting. Recruitment for the study will occur at approximately 150 trial sites globally and is designed to enroll approximately 550 adult patients with HER2-positive breast cancer participate. For more information about this study and participating sites, visit clinicaltrials.gov (and search “NCT06435429”) or click here, or email clinicaltrialdisclosure@jazzpharma.com.