Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

JRCT ID: jRCT2031240223

Registered date:19/07/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: advanced or metastatic HER2-positive biliary tract cancer
• Date of first enrollment: 24/09/2024
• Target sample size: 49
• Countries of recruitment: Argentina,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,Czech Republic,Japan,Finland,Japan,France,Japan,Germany,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Portugal,Japan,Romania,Japan,Serbia,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): For subjects weighing less than 70 kg, 1,800 mg is administered IV on Day 1 of each 21-day cycle. For subjects weighing 70 kg or more, 2,400 mg is administered IV on Day 1 of each 21-day cycle.

Outcome(s)

Primary Outcome

Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors [Time Frame: Up to 52 months]

PFS is defined as the time from the date of randomization to the date of documented disease progression, or death from any cause.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Histologically- or cytologically-confirmed Biliary Tract Cancer (BTC), including 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 a PD-1/L1 inhibitor (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+) 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.

Assessable (measurable or non-measurable) disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), per investigator assessment.

Male or female, 18 years or older (or the legal age of adulthood per country-specific regulations).

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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.

Exclude criteria

Prior treatment with a HER2-targeted agent.

Prior treatment with checkpoint inhibitors, other than durvalumab or pembrolizumab.

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.

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.

Related Information

• Primary Sponsor: Oki Kosuke
• Secondary ID(s): NCT06282575,2023-508219-21-00