NCT04837508

A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Shanghai Miracogen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 as single agent in HER2-positive unresectable locally advanced or metastatic biliary tract cancer patients who have progressed during or relapsed after at least one prior stand therapy.

Detailed description

The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.

Conditions

• Advanced or Metastatic Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	MRG002	Administrated intravenously

Timeline

• Start date: 2021-06-07
• Primary completion: 2022-12-01
• Completion: 2023-08-01
• First posted: 2021-04-08
• Last updated: 2021-12-10

Locations

7 sites across 1 country: China