NCT06282575 Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
| NCT ID | NCT06282575 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Jazz Pharmaceuticals |
| Condition | Biliary Tract Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 286 participants |
| Start Date | 2024-07-19 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 286 participants in total. It began in 2024-07-19 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria 1. Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC). 2. Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. 3. Received no more than 2 cycles of systemic therapy which is limited to Cisplatin and Gemcitabine (CisGem) with or without a PD-1/L1 inhibitor (physician's choice of durvalumab or pembrolizumab, where approved under local regulations) for advanced unresectable or metastatic disease. 4. HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) by IHC and in situ Hybridization (ISH) assay (in participants with IHC 2+ tumors) at a central laboratory on new biopsy tissue or archival tissue from the most recent biopsy. 5. Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment. 6. Male or female ≥ 18 years or age (or the legal age of adulthood per country-specific regulations). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Adequate organ function 9. Females of childbearing potential must have a negative pregnancy test result. 10. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control. Exclusion Criteria 1. Prior treatment with a HER2-targeted agent 2. Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab 3. The following BTC histologic subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region. 4. Use of systemic corticosteroids. 5. Brain metastases 6. Severe chronic or active infections 7. History of allogeneic organ transplantation. 8. Active or prior autoimmune inflammatory conditions 9. History of interstitial lung disease or non-infectious pneumonitis. 10. Participation in another clinical trial with an investigational medicinal product within the last 3 months. 11. Females who are breastfeeding 12. Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures. 13. Use of phenytoin
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06282575 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Biliary Tract Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06282575 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 286 participants.
Is NCT06282575 currently recruiting?
Yes, NCT06282575 is actively recruiting participants. Contact the research team at ClinicalTrialDisclosure@JazzPharma.com for enrollment information.
Where is the NCT06282575 trial being conducted?
This trial is being conducted at Duarte, United States, Lone Tree, United States, Orlando, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT06282575 clinical trial?
NCT06282575 is sponsored by Jazz Pharmaceuticals. The trial plans to enroll 286 participants.
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