NCT06178588

Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Previously Treated Locally Advanced, Recurrent, or Metastatic Cholangiocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced), that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a toxic agent, called SN-38. HRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as TROP2 receptors, and delivers SN-38 to kill them.

Detailed description

PRIMARY OBJECTIVE: I. To determine anti-tumor activity by overall response rate (ORR). SECONDARY OBJECTIVES: I. To determine treatment safety based on toxicities participants who have received at least one dose of sacituzumab govitecan. II. To determine anti-tumor activity by progression free survival (PFS). III. To determine anti-tumor activity by disease control rate (DCR). IV. To determine overall survival (OS). EXPLORATORY OBJECTIVES: I. To determine if treatment will result in reduction of the circulating tumor deoxyribonucleic acid (DNA) as a measure of therapeutic response. II. To determine relationship between tumor mutational profile (already performed as standard of care next generation sequencing \[NGS\] based test) to response. OUTLINE: Patients receive sacituzumab govitecan intravenously (IV) over 1-3 hours on days 1 and 8 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy, positron emission tomography (PET)/computed tomography (CT) or magnetic resonance imaging (MRI) scans, and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days, and every 3 months for up to 24 months.

Conditions

• Locally Advanced Cholangiocarcinoma
• Metastatic Cholangiocarcinoma
• Recurrent Cholangiocarcinoma
• Stage III Hilar Cholangiocarcinoma AJCC v8
• Stage III Intrahepatic Cholangiocarcinoma AJCC v8
• Stage IV Hilar Cholangiocarcinoma AJCC v8
• Stage IV Intrahepatic Cholangiocarcinoma AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo PET/CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
BIOLOGICAL	Sacituzumab Govitecan	Given IV

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-03-01
• Completion: 2026-11-01
• First posted: 2023-12-21
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study