WINIT-BC: Intratumoral Mitazalimab in Breast Cancer

This study is looking at a new way to treat breast cancer before surgery. Researchers are testing a drug called Mitazalimab, which is an agonistic CD40 antibody, either by itself or with another drug called Nivolumab (a checkpoint inhibitor). These drugs are injected directly into the tumor. The main goals are to see if these treatments are safe (looking for serious side effects within 30 days) and practical to give before surgery (making sure surgery isn't delayed). They also want to see how these drugs affect the tumor and the body's immune system. You could be eligible if you are at least 18 years old, weigh over 40kg, and have Stage I-III or recurrent breast cancer that can be removed by surgery.

Study design
This is an interventional study with a planned enrollment of 32 participants. It is not specified if it's a randomized or blinded study.
What's involved
Participants will receive a single injection of the study drug into their tumor at least 7 days before their planned surgery. They will then be monitored for safety and other effects.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety within 30 days of treatment and for feasibility up to 14 days after their planned surgical date.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07319195

Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Jennifer Zhang
~32 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Intratumoral MitazalimabIntratumoral Nivolumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0
Measured over Within 30 days of treatment
+1 more outcome measured
Breast Cancer
1 sites across 1 states
Pennsylvania1
  • Jennifer Zhang, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Opens a ready-to-send draft in your own email app — review before sending.

  • Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0Within 30 days of treatment

    Type and severity of adverse events

  • Feasibility of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab) prior to surgery14 days after planned surgical date

    Number of successful surgical resection without unanticipated delay in surgery \> 14 days after planned surgical date due to treatment-related issues