| Study Name |
|
Herizon BTC-302 An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard of care therapy alone for advanced HER2 positive biliary tract cancer |
| ClinicalTrials.gov Identifier (if applicable) |
|
NCT06282575 |
| Clinical Trial Category (check all that apply) |
|
- First Line Therapy
- Chemotherapy
- Targeted Therapy
- Immunotherapy
|
| Study Center |
| Institution Name |
|
Multiple Sites (see below) |
| Country |
|
United States |
| List additional Institutions (include address, phone number, and website) |
|
1) Hospital Oncologico, Puerto Rico Medical Center
Second Floor, Barrio Monacillos
Rio Piedras, Puerto Rico, USA 00935
Telephone: 787-407-3333
Website: https://panoncologytrials.com/
2) SCRI Oncology Partners
335 24th Avenue North, Suite 200
Nashville, TN USA 37203
Telephone: 844-482-4812
Website: https://sarahcannon.com/
3) Texas Oncology – DFW
Dallas, TX 75246
4) Minnesota Oncology Hematology, P.A.
Maple Grove, MN 55369
5) Rocky Mountain Cancer Centers, LLP
Lone Tree, CO 80124 |
| Study Contacts |
| List additional Principal Investigators (include phone number and email) |
|
1) Karina Arocho-Gonzalez, MD
Telephone: 787-407-3333
https://panoncologytrials.com/
2) Meredith Sellers Pelster, MD
Telephone: 844-482-4812
Connect With Us | Sarah Cannon |
| Study Coordinator |
|
Multiple Study Coordinators (see below) |
| List additional Study Coordinators (include phone number and email) |
|
1) Isamar Alicea
Telephone: 787-407-3333
https://panoncologytrials.com/
2) Referral Line
Telephone: 844-482-4812
Connect With Us | Sarah Cannon. |
| OVERVIEW – in layman’s terms (150 words max) |
|
To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer. |
| Enrollment |
|
286 patients |
| Study Start Date |
|
02/09/2024 |
| Estimated Completion Date |
|
11/01/2029 |
| Purpose of the Study – in Layman’s Terms (use the “+” to add more list items) |
|
- The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician’s choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer.
|
| Inclusion Criteria – Patients Must: |
|
- Have diagnosed Biliary Tract Cancer (BTC) (Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC)).
- Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies.
- Received no more than 2 cycles of systemic therapy with gemcitabine and a platinum agent with or without your physician’s choice of durvalumab or pembrolizumab, where approved under local regulations for advanced unresectable or metastatic disease.
- HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) a central laboratory on new or archival tissue.
- Radiographically assessable (by CT scan or MRI)
- Male or female ≥ 18 years
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test result.
- Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
|
| Exclusion Criteria – Patients Must NOT: |
|
- Prior treatment with a HER2-targeted agent
- Prior treatment with checkpoint inhibitors (other than the durvalumab or pembrolizumab as described in inclusion criterion 3)
- The following cancer subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region
- Use of systemic corticosteroids
- Brain metastases
- Severe chronic or active infections
- History of allogeneic organ transplantation
- Active or prior autoimmune inflammatory conditions
- History of interstitial lung disease or non-infectious pneumonitis
- Participation in another clinical trial with an investigational medicinal product within the last 3 months
- Females who are breastfeeding
- Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
|
| REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms |
|
- HER2 diagnostic test, which will be determined by your health care team
|
| POTENTIAL SIDE-EFFECTS – in layman’s terms |
|
- Mild or moderate reactions related to the infusion
- Mild or moderate (usually managed at home) diarrhea
- Mild or moderate (usually managed at home) nausea
- Altered blood counts
|
| Financial Assistance is available to participants for travel, lodging, etc. |
|
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