Overview

Phase 1/2a Open-label Trial of BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors

Status:
Recruiting

Trial end date:
2026-12-01

Target enrollment:

Participant gender:

Summary

HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607, a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targets CD32b (Fc Gamma Receptor IIB), it is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab. This is a Phase 1/2a, first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors whose tumor has progressed after standard therapy.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

BioInvent International AB

Treatments:

Trastuzumab