Study on the Effects and Safety of Pumitamig for Patients with Triple-Negative Breast Cancer

Sponsor: BioNTech SE

Sponsor score: 0

ClinicalTrials ID:NCT07173751

Provider View

This clinical trial is testing a new drug called Pumitamig, combined with chemotherapy, to see if it is safe and effective for patients with triple-negative breast cancer. Participants will be randomly assigned to receive either the trial drug or a placebo, along with chemotherapy.

Patient Parameters

Program Overview

This study aims to evaluate the safety and effectiveness of a new drug, Pumitamig, in combination with chemotherapy for patients with triple-negative breast cancer. Participants will be randomly assigned to one of two groups: one group will receive Pumitamig with chemotherapy, and the other will receive a placebo with chemotherapy. The trial is double-blinded, meaning neither the participants nor the doctors will know who is receiving the actual drug or the placebo.

Description

The study includes several phases:

  1. Screening Period: Lasts up to 28 days to determine eligibility.
  2. Treatment Period: Participants will receive either Pumitamig or a placebo, both combined with chemotherapy, until the cancer progresses, side effects become intolerable, the participant withdraws, passes away, or the trial ends.
  3. Safety Follow-Up: Lasts up to 90 days after the last dose to monitor any side effects.
  4. Survival Follow-Up: Continues until the participant passes away, withdraws consent, loses contact, or the sponsor decides to end it.

Participants will be randomly assigned to receive either Pumitamig with chemotherapy (Arm 1) or a placebo with chemotherapy (Arm 2). The chemotherapy will follow standard medical practices. The randomization will consider factors like previous cancer immunotherapy, the type of chemotherapy regimen, geographic location, and PD-L1 status.

Eligibility Criteria

Inclusion Criteria

  • Cannot receive a specific type of immunotherapy plus chemotherapy due to their tumor's PD-L1 status.
  • Have confirmed locally recurrent inoperable or metastatic triple-negative breast cancer, or certain types of estrogen receptor-low, HER2-negative breast cancer.
  • Have at least one measurable tumor.
  • Have provided a tissue sample during screening (certain types of samples are not acceptable).
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have received certain cancer treatments or drugs before starting the trial.
  • Have used systemic corticosteroids above a certain dose recently, with some exceptions.
  • Have been vaccinated with live vaccines recently.
  • Have used broad-spectrum intravenous antibiotics recently.
  • Are pregnant, breastfeeding, or planning to become pregnant or father children during the trial or shortly after.
  • Have had major surgery, significant trauma, or invasive dental procedures recently or plan to have elective surgery during the trial.
  • Have had a stem cell or organ transplant.

Locations

FACILITYZIPCITYSTATE
Profound Research LLC at Michigan Hematology and Oncology Consultants48073Royal OakMichigan

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