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

NCT07319195 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-06

No results posted yet for this study

Summary

The goal of this clinical trial is to study the safety, feasibility, histologic and immunological effects of Mitazalimab, a CD40 agonistic antibody, when administered either alone or in combination with PD-1 inhibition prior to surgical resection.

The investigator hypothesizes that preoperative administration of CD40 agonist with or without PD-1 inhibitor intratumorally will demonstrate an acceptable safety profile, will not result in an unplanned delay in surgery, and will lead to increased immune activation.

Subjects will receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery and will be followed for safety, feasibility, immune, and pathologic responses.

Conditions

Interventions

DRUG

Intratumoral Mitazalimab

Intratumoral agonistic CD40

DRUG

Intratumoral Nivolumab

Checkpoint inhibitor

Sponsors & Collaborators

  • Alligator Bioscience AB

    collaborator INDUSTRY

  • Jennifer Zhang

    lead OTHER

Principal Investigators

  • Jennifer Zhang, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-27
Primary Completion
2028-04-30
Completion
2033-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07319195 on ClinicalTrials.gov