ClinicaliQ Trial Snapshot
- Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer — Recruiting • Phase III • Oncology • NCT06282575.
- What is being tested: Zanidatamab (a HER2-directed bispecific antibody) combined with standard chemotherapy (Cisplatin/Gemcitabine ± PD-1/L1 inhibitor) versus chemotherapy alone in advanced HER2-positive biliary tract cancer.
- Patient eligibility overview: Adults with unresectable or metastatic HER2-positive biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer) who are treatment-Phase IIIïve and have adequate performance status and organ function.
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What This Trial Is Studying
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 Snapshot
- 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.