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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Jennifer Zhang
Study ID
NCT07319195
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intratumoral Mitazalimab — DRUG
    Intratumoral agonistic CD40
  • Intratumoral Nivolumab — DRUG
    Checkpoint inhibitor

Study Details

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.

Key Dates

Start date
Apr 27, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2033

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mitazalimab 22.5 μg/kg
    Arm A, Dose Level -1 (DL-1): Mitazalimab 22.5 μg/kg. This dose level will only be explored if ≥ 2 DLTs occur at any time in DL1.
  • Experimental: Mitazalimab 75 μg/kg
    Arm A, Dose Level 0 (DL0): Mitazalimab 75 μg/kg
  • Experimental: Mitazalimab 200 μg/kg
    Arm A, Dose Level 1 (DL1): Mitazalimab 200 μg/kg
  • Experimental: Mitazalimab 22.5 μg/kg + Nivolumab
    Arm B, Dose Level -1 (DL-1): Mitazalimab 22.5 μg/kg + Nivolumab. This dose level will only be explored if ≥ 2 DLTs occur at any time in DL1.
  • Experimental: Mitazalimab 75 μg/kg + Nivolumab
    Arm B, Dose Level 0 (DL0): Mitazalimab 75 μg/kg + Nivolumab
  • Experimental: Mitazalimab 200 μg/kg + Nivolumab
    Arm B, Dose Level 1 (DL1): Mitazalimab 200 μg/kg + Nivolumab

Primary Outcome Measure

Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0 [ Time Frame: Within 30 days of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Jennifer Zhang, MD
[email protected]
215-573-9348
Julia Lewandowski
[email protected]
215-573-9348

Find similar trials in Philadelphia, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

Related Studies