Mitazalimab for Breast Cancer
(WINIT-BC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effects of Mitazalimab, a new treatment for breast cancer, administered alone or with Nivolumab (an immunotherapy drug), before surgery. Researchers hope these treatments will safely enhance the immune system's response to cancer without delaying surgery. Individuals with Stage I-III or recurrent breast cancer who plan to undergo surgery and are not currently receiving other cancer treatments may be suitable for this trial. As an Early Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier research has shown that Mitazalimab is safe when combined with chemotherapy. For instance, patients with pancreatic cancer tolerated it well, and the data revealed no major unexpected issues.
Nivolumab, part of the treatment in this trial, is already used for other cancer types. Research indicates that while some patients experienced immune-related side effects when Nivolumab was combined with other drugs, serious reactions were uncommon.
As this trial is in its early stages, the main goal is to assess safety. Early-phase trials often have limited safety information. Participants will be closely monitored for any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Mitazalimab because it targets the CD40 receptor, which plays a key role in activating the immune system to fight cancer. Unlike traditional chemotherapy that attacks cancer cells directly, Mitazalimab enhances the body's own immune response. When combined with Nivolumab, an immune checkpoint inhibitor, it potentially offers a powerful one-two punch against breast cancer. This combination could lead to more effective treatments with potentially fewer side effects compared to current options like chemotherapy or hormone therapy.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will evaluate Mitazalimab, both alone and with Nivolumab, for breast cancer. Studies have shown that Mitazalimab, when combined with chemotherapy, produced promising results in treating pancreatic cancer, with many patients responding well and living longer. This suggests potential usefulness for other cancers, such as breast cancer. Mitazalimab activates a protein called CD40, aiding the immune system in attacking cancer cells.
In early studies of Mitazalimab combined with Nivolumab for breast cancer, similar treatments, like Nivolumab, have improved patient response and survival rates. This combination aims to enhance the immune system's ability to locate and destroy cancer cells. Although research remains in the early stages, these findings offer hope for improved breast cancer treatment outcomes.13678Who Is on the Research Team?
Jennifer Zhang, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intratumoral dose of CD40 agonist with or without PD-1 inhibitor 7 or more days prior to surgery
Surgery
Surgical resection of the tumor is performed
Follow-up
Participants are monitored for safety, feasibility, immune, and pathologic responses after treatment
Long-term Follow-up
Participants are monitored for recurrence of disease and event-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Mitazalimab
- Nivolumab
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Arm B, Dose Level 0 (DL0): Mitazalimab 75 μg/kg + Nivolumab
Arm A, Dose Level 0 (DL0): Mitazalimab 75 μg/kg
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.
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.
Arm B, Dose Level 1 (DL1): Mitazalimab 200 μg/kg + Nivolumab
Arm A, Dose Level 1 (DL1): Mitazalimab 200 μg/kg
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Zhang
Lead Sponsor
Alligator Bioscience AB
Industry Sponsor
Citations
Mitazalimab Plus Chemo Demonstrates Potential OS ...
The combination of mitazalimab and mFOLFIRINOX showed a median overall survival of 14.9 months in metastatic pancreatic cancer patients. The ...
Biomarkers associated with outcomes from OPTIMIZE-1
The OPTIMIZE-1 Phase 1b/2 trial evaluated the safety and efficacy of mitazalimab combined with mFOLFIRINOX (mFFX) in treatment naïve mPDAC patients (pts).
3.
targetedonc.com
targetedonc.com/view/final-data-show-continued-responses-safety-by-mitazalimab-in-pancreatic-cancerFinal Data Show Continued Responses, Safety by ...
Mitazalimab, combined with chemotherapy, achieved a 54.4% objective response rate and 12.6-month median response duration in metastatic ...
4.
cancernetwork.com
cancernetwork.com/view/mitazalimab-chemo-yields-promising-survival-responses-in-untreated-pdacMitazalimab/Chemo Yields Promising Survival/Responses ...
At 30 months, mitazalimab plus mFOLFIRINOX achieved an OS rate of 21% in patients with previously untreated metastatic PDAC.
Advances in Breast Cancer Research: Immunological ... - PMC
Overall, while DC vaccines show considerable promise, their antitumor efficacy appears highly dependent on synergistic combinations with ...
An interim analysis of the optimize-1 phase 1b/2 study.
Conclusions: Mitazalimab + mFOLFIRINOX is a feasible regimen with a manageable safety profile. Mitazalimab administered at 900 µg/kg in combination with ...
265P CD40 agonist mitazalimab + mFOLFIRINOX in ...
The study met its primary endpoint with promising clinical efficacy vs. historical controls: median overall survival (mOS) 14.9 months, median duration of ...
Study Details | NCT07437287 | Testing Mitazalimab in ...
The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard ...
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