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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

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

Oki Kosuke

PPD-SNBL K. K.

St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo

kosuke.oki@thermofisher.com

Oki Kosuke

PPD-SNBL K. K.

St Luke's Tover 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo

+81-80-6787-6873

kosuke.oki@thermofisher.com

Recruiting

Sept. 24, 2024

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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.

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.

Use of phenytoin

Both

advanced or metastatic HER2-positive biliary tract cancer

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.

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.

+81-43-264-5431

Aug. 21, 2024

No

Argentina/Belgium/Brazil/Canada/Chile/China/Czech Republic/Finland/France/Germany/India/Israel/Italy/Korea/Portugal/Puerto Rico/Romania/Serbia/Spain/Sweden/Taiwan/Turkey/United Kingdom/United States