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BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

NCT05555251 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BI-1607

administered at different doses in Phase I by intravenous infusions every 3 weeks.

DRUG

BI-1607

administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.

DRUG

Trastuzumab

administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.

Sponsors & Collaborators

  • BioInvent International AB

    lead INDUSTRY

Principal Investigators

  • Andres McAllister, MD, PhD · BioInvent International AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-28
Primary Completion
2024-02-07
Completion
2024-02-07

Countries

  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555251 on ClinicalTrials.gov