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

NCT07319195 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 858844
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

resectable breast cancer

Outcome Measures

Primary Outcomes (2)

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

  Type and severity of adverse events

  Within 30 days of treatment

• Feasibility of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab) prior to surgery

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

  14 days after planned surgical date

Secondary Outcomes (9)

• Tumor response rate

  2 weeks after surgery

• Recurrence of disease

  up to 5 years post surgery

• Event-free survival

  up to 5 years post surgery

• Immunologic effects of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab)

  Prior to treatment and up to 30 days post surgery

• Number of participants with change in serum cytokine levels pre- and post-treatment

  Prior to treatment and up to 30 days post surgery

Study Arms (6)

Mitazalimab 22.5 μg/kg

EXPERIMENTAL

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.

Drug: Intratumoral Mitazalimab

Mitazalimab 75 μg/kg

EXPERIMENTAL

Arm A, Dose Level 0 (DL0): Mitazalimab 75 μg/kg

Drug: Intratumoral Mitazalimab

Mitazalimab 200 μg/kg

EXPERIMENTAL

Arm A, Dose Level 1 (DL1): Mitazalimab 200 μg/kg

Drug: Intratumoral Mitazalimab

Mitazalimab 22.5 μg/kg + Nivolumab

EXPERIMENTAL

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.

Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab

Mitazalimab 75 μg/kg + Nivolumab

EXPERIMENTAL

Arm B, Dose Level 0 (DL0): Mitazalimab 75 μg/kg + Nivolumab

Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab

Mitazalimab 200 μg/kg + Nivolumab

EXPERIMENTAL

Arm B, Dose Level 1 (DL1): Mitazalimab 200 μg/kg + Nivolumab

Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab

Interventions

Intratumoral Mitazalimab DRUG

Intratumoral agonistic CD40

Mitazalimab 200 μg/kg; Mitazalimab 200 μg/kg + Nivolumab; Mitazalimab 22.5 μg/kg; Mitazalimab 22.5 μg/kg + Nivolumab; Mitazalimab 75 μg/kg; Mitazalimab 75 μg/kg + Nivolumab

Intratumoral Nivolumab DRUG

Checkpoint inhibitor

Mitazalimab 200 μg/kg + Nivolumab; Mitazalimab 22.5 μg/kg + Nivolumab; Mitazalimab 75 μg/kg + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written IRB-approved informed consent.
• Age ≥18 years.
• Body weight \> 40kg
• Stage I-III or recurrent resectable breast cancer to be treated with curative-intent
• Planning to undergo upfront surgery as part of routine clinical care
• Discussion with the treating or study medical oncologist re: the potential of sending an Oncotype evaluation (if ER+HER2-) on the core needle biopsy sample
• Availability of the core needle biopsy sample for correlative studies
• Surgery to be performed at a University of Pennsylvania Hospital
• Life expectancy of at least 12 weeks.
• Adequate bone marrow, hepatic, and renal function. ANC (Absolute Neutrophil Count) ≥ 1.5x109 cell/ml, platelets ≥75,000 /mm3, hemoglobin ≥9.0 g/dL, total serum bilirubin within 1.5 x upper limit of normal (ULN) unless Gilbert's, AST/ALT, within 2.5 x ULN, Albumin ≥3g/dL, and all tests performed within 4 weeks prior to administration of Study Treatment.
• ECG with no clinically significant findings as assessed by the investigator.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
• Female patients of childbearing potential who are not abstinent and intend to be sexually active with a non-sterilized male partner must use at least 1 highly effective method of contraception from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after therapy). Non-sterilized male partners of a female patient of childbearing potential must use male condom plus spermicide throughout this period. Female patients should also refrain from breastfeeding throughout this period.
• Able and willing to comply with all study procedures.

You may not qualify if:

• Metastatic disease.
• Planned neoadjuvant therapy, i.e., not undergoing upfront surgery.
• Known history of hepatitis B or C with active viral replication.
• Administration of any live vaccine within 28 days of first dose of study treatment.
• Prior CD40 or anti-PD-1 agonist therapy.
• Participation in another interventional clinical trial within 30 days before receiving first dose of study treatment. However, the subject may participate in observational studies.
• Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.
• Current or prior use of immunosuppressive medication within 14 days before study treatment. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
• Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
• History of allogenic organ transplantation
• Active or prior documented autoimmune disease. Examples include inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis\], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]. The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or type 1 DM controlled with insulin

Sponsors & Collaborators

• Jennifer Zhang: lead
• Alligator Bioscience AB: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Zhang, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Zhang, MD

CONTACT

215-573-9348; jennifer.zhang@pennmedicine.upenn.edu

Julia Lewandowski

CONTACT

215-573-9348; julia.lewandowski@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery at the Hospital of the University of Pennsylvania

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 6, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2033
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)