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Monoclonal Antibodies

Phase I -Dose escalation for Breast Cancer (CONTRAST Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by BioInvent International AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the last dose of bi-1607
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Breast Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Stomach Cancer
  • Gastric Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment visit or 30 days after last dose of study drug.
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment visit or 30 days after last dose of study drug. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Trastuzumab
Trastuzumab
Secondary study objectives
Trastuzumab
Trastuzumab
Pyruvate Kinase
+1 more
Other study objectives
Serum
Exploratory: investigate expression levels of Fc receptors, and other immunological markers on immune cells infiltrating the tumor
Exploratory: investigate the genetic background of subjects with respect to FcgammaR isoforms and explore a potential correlation of the genetic background with clinical responses

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase I -Dose escalationExperimental Treatment2 Interventions
Dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors.
Group II: Phase 2a - Expansion cohortsExperimental Treatment2 Interventions
Dose expansion study of BI-1607 combined with trastuzumab in cohort 1: HER2 positive locally advanced or metastatic HER2+ breast cancer and cohort 2: metastatic gastric or gastroesophageal junction adenocarcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

BioInvent International ABLead Sponsor
17 Previous Clinical Trials
1,719 Total Patients Enrolled
Andres McAllister, MD, PhDStudy DirectorBioInvent International AB
~6 spots leftby Nov 2025
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