Study to Find the Best Dose of New Treatments BNT323 and BNT327 for Advanced Breast Cancer

Sponsor: BioNTech SE

Sponsor score: 0

ClinicalTrials ID:NCT06827236

Provider View

This clinical trial is testing a combination of two new treatments, BNT323 and BNT327, to find the best dose and see if they are safe and effective for patients with advanced breast cancer.

Patient Parameters

Program Overview

This study is in two parts and aims to find out if a combination of two new treatments, BNT323 and BNT327, is safe and effective for patients with advanced breast cancer. It includes patients with different types of breast cancer, such as hormone receptor-positive or negative, and those with low levels of a protein called HER2.

Description

The study has two main parts:

  • Part 1 - Dose Escalation: In this part, patients with advanced breast cancer who have already had chemotherapy will receive different doses of BNT323 and BNT327 together. The goal is to find the best dose to use in the next phase of the study.

  • Part 2 - Dose Optimization and Exploratory Cohorts: This part will start after Part 1 is completed. It will test the best dose found in Part 1 to see how well it works and how safe it is. There will be three groups in this part:

    • Cohort 1: Patients will be randomly assigned to receive either the best dose of BNT323 and BNT327, a lower dose, or one of the treatments alone.
    • Cohorts 2 and 3: These groups will explore other aspects of the treatment.

The study aims to provide a better understanding of how these new treatments work compared to other options.

Eligibility Criteria

Exclusion Criteria

  • Have had a small bowel obstruction needing hospital care in the last 3 months.
  • Have an illness that is not controlled and could make it hard to follow the study or increase the risk of side effects.
  • Have fluid buildup around the lungs, heart, or abdomen that needs draining or other treatments within 2 weeks before joining the study.
  • Have a history of lung disease that needed steroids or have current lung issues that cannot be ruled out by imaging.
  • Have had certain treatments before, like topoisomerase I inhibitors or specific antibodies.
  • Have used certain immune system drugs or high-dose steroids recently.

Note: There may be other criteria for joining or not joining the study.

Locations

FACILITYZIPCITYSTATE
Hematology - Oncology Associates of the Treasure Coast34952Port Saint LucieFlorida

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