Breast CancerEarly Phase 1WINIT-BCNCT07319195
Window Study of Intratumoral Mitazalimab in Breast Cancer (WINIT-BC)
A Early Phase 1 study testing Intratumoral Mitazalimab and Intratumoral Nivolumab in people with Breast Cancer, run by Jennifer Zhang at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intratumoral Mitazalimab and Intratumoral Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to Apr 2033
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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
- Any chronic skin condition that does not require systemic therapy
- Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- History of another active malignancy except for non-melanoma skin cancer, lentigo maligna or other carcinoma in situ
- History of active primary immunodeficiency
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Body weight > 110 kg.
- Actively breastfeeding. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Jennifer Zhang, MD, 215-573-9348, jennifer.zhang@pennmedicine.upenn.edu
Julia Lewandowski, 215-573-9348, julia.lewandowski@pennmedicine.upenn.edu
About this study
Official title: Window of Opportunity Study of Intratumoral CD40 Agonist (Mitazalimab) With or Without PD-1 Inhibitor (Nivolumab) in Patients With Resectable Breast Cancer (WINIT-BC)
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
- Being tested
- Intratumoral Mitazalimab, Intratumoral Nivolumab
- Keywords
- resectable breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intratumoral MitazalimabDrug
Intratumoral agonistic CD40
Intratumoral NivolumabDrug
Checkpoint inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intratumoral Mitazalimab |
| Mitazalimab 75 μg/kg | Experimental | Arm A, Dose Level 0 (DL0): Mitazalimab 75 μg/kg Receives: Drug: Intratumoral Mitazalimab |
| Mitazalimab 200 μg/kg | Experimental | Arm A, Dose Level 1 (DL1): Mitazalimab 200 μg/kg Receives: 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. Receives: Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab |
| Mitazalimab 75 μg/kg + Nivolumab | Experimental | Arm B, Dose Level 0 (DL0): Mitazalimab 75 μg/kg + Nivolumab Receives: Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab |
| Mitazalimab 200 μg/kg + Nivolumab | Experimental | Arm B, Dose Level 1 (DL1): Mitazalimab 200 μg/kg + Nivolumab Receives: Drug: Intratumoral Mitazalimab; Drug: Intratumoral Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0
Type and severity of adverse events
Measured: 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
Measured: 14 days after planned surgical date
Secondary outcomes (9)
Tumor response rate
Rate of tumors with response (Residual Cancer Burden 0-II)
Measured: 2 weeks after surgery
Recurrence of disease
Occurrence of a breast cancer recurrence
Measured: up to 5 years post surgery
Event-free survival
Length of time between time of surgery and a breast cancer recurrence or death
Measured: up to 5 years post surgery
Immunologic effects of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab)
Immunophenotyping of PBMCs pre- and post-treatment
Measured: Prior to treatment and up to 30 days post surgery
Number of participants with change in serum cytokine levels pre- and post-treatment
Serum cytokine measurement
Measured: Prior to treatment and up to 30 days post surgery
Number of participants with changes in tumor immune cell number pre- and post-treatment
10x genomics platform will be used to evaluate for changes in tumor immune cell number pre- and post-treatment
Measured: Prior to treatment and up to 30 days post surgery
Number of participants with changes in TCR repertoire in peripheral blood pre- and post-treatment
Comparison of TCR repertoire in peripheral blood via TCR sequencing pre- and post-treatment
Measured: Prior to treatment and up to 30 days post surgery
Number of participants with changes in TCR repertoire in tumor pre- and post-treatment
Comparison of TCR repertoire in tumor via TCR sequencing pre- and post-treatment
Measured: Prior to treatment and up to 30 days post surgery
Number of patients with FDG PET/CT response or flair after treatment
Change in FDG activity in tumor and/or lymph nodes between baseline (PET0) and post-treatment (PET1) FDG PET/CT scans.
Measured: between baseline and 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start27 Apr 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Alligator Bioscience AB
- Responsible party
- Sponsor-investigator, Jennifer Zhang, University of Pennsylvania
- Investigators
- Jennifer Zhang, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319195
- Sponsor's protocol ID
- 858844
- Acronym
- WINIT-BC
- Status last verified
- Apr 2026
- First submitted
- 26 Nov 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window of Opportunity Study of Intratumoral CD40 Agonist (Mitazalimab) With or Without PD-1 Inhibitor (Nivolumab) in Patients With Resectable Breast Cancer (WINIT-BC)
- ClinicalTrials.gov ID
- NCT07319195
- Acronym / sponsor ID
- WINIT-BC / 858844
- Conditions
- Breast Cancer
- Keywords
- resectable breast cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Jennifer ZhangUniversity, hospital or other
- Collaborators
- Alligator Bioscience AB
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2033 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Mitazalimab 22.5 μg/kg | Experimental | Drug: Intratumoral MitazalimabArm 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. |
| Mitazalimab 75 μg/kg | Experimental | Drug: Intratumoral MitazalimabArm A, Dose Level 0 (DL0): Mitazalimab 75 μg/kg |
| Mitazalimab 200 μg/kg | Experimental | Drug: Intratumoral MitazalimabArm A, Dose Level 1 (DL1): Mitazalimab 200 μg/kg |
| Mitazalimab 22.5 μg/kg + Nivolumab | Experimental | Drug: Intratumoral Mitazalimab, Drug: Intratumoral NivolumabArm 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. |
| Mitazalimab 75 μg/kg + Nivolumab | Experimental | Drug: Intratumoral Mitazalimab, Drug: Intratumoral NivolumabArm B, Dose Level 0 (DL0): Mitazalimab 75 μg/kg + Nivolumab |
| Mitazalimab 200 μg/kg + Nivolumab | Experimental | Drug: Intratumoral Mitazalimab, Drug: Intratumoral NivolumabArm B, Dose Level 1 (DL1): Mitazalimab 200 μg/kg + Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intratumoral MitazalimabIntratumoral agonistic CD40 | Drug | 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 NivolumabCheckpoint inhibitor | Drug | Mitazalimab 200 μg/kg + Nivolumab, Mitazalimab 22.5 μg/kg + Nivolumab, Mitazalimab 75 μg/kg + Nivolumab |
Primary outcome
Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0
Time frame: Within 30 days of treatment
Type and severity of adverse events
Feasibility of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab) prior to surgery
Time frame: 14 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
9 secondary outcomes
Tumor response rate
Time frame: 2 weeks after surgery
Recurrence of disease
Time frame: up to 5 years post surgery
Event-free survival
Time frame: up to 5 years post surgery
Immunologic effects of CD40 agonist (Mitazalimab) with/without PD-1 inhibitor (Nivolumab)
Time frame: Prior to treatment and up to 30 days post surgery
Number of participants with change in serum cytokine levels pre- and post-treatment
Time frame: Prior to treatment and up to 30 days post surgery
Number of participants with changes in tumor immune cell number pre- and post-treatment
Time frame: Prior to treatment and up to 30 days post surgery
Number of participants with changes in TCR repertoire in peripheral blood pre- and post-treatment
Time frame: Prior to treatment and up to 30 days post surgery
Number of participants with changes in TCR repertoire in tumor pre- and post-treatment
Time frame: Prior to treatment and up to 30 days post surgery
Number of patients with FDG PET/CT response or flair after treatment
Time frame: between baseline and 1 week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Zhang, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intratumoral Mitazalimab and Intratumoral Nivolumab in people with Breast Cancer, run by Jennifer Zhang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Zhang, MD (215-573-9348, jennifer.zhang@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Grade 3 or higher adverse events as assessed by CTCAE v5.0 (time frame: Within 30 days of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.