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.

Start Date01 Mar 2026

Sponsor / Collaborator

University of Pennsylvania

[+1]

NCT07199764

/ RecruitingPhase 2IIT

IGNITE: A Phase 2 Study of Maintenance Combinatorial Myeloid Immunotherapy in Patients With Unresectable Pancreatic Ductal Adenocarcinoma

Phase II, open-label, single-arm study of CD40/Dectin-1 immunotherapy as maintenance treatment in patients with unresectable pancreatic ductal adenocarcinoma (PDA) who have not progressed following 4-6 months of first line (1L) chemotherapy.

Start Date25 Nov 2025

Sponsor / Collaborator

University of Pennsylvania

[+1]

NCT06205849

/ RecruitingPhase 1IIT

Phase 1 Clinical Trial of Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer

This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.

Start Date25 Jun 2024

Sponsor / Collaborator

University of California San Diego

[+2]

100 Clinical Results associated with Mitazalimab

100 Translational Medicine associated with Mitazalimab

100 Patents (Medical) associated with Mitazalimab

Literatures (Medical) associated with Mitazalimab

01 Oct 2025·Cell Reports Medicine

CD40 agonist mitazalimab with mFOLFIRINOX in untreated metastatic pancreatic cancer: Biomarkers associated with outcomes from OPTIMIZE-1

Article

Author: Feliu, Jaime ; Pilla, Lorenzo ; Geboes, Karen ; Cassier, Philippe ; Gallego, Inmaculada ; Nordbladh, Karin ; Van Laethem, Jean-Luc ; Ambarkhane, Sumeet Vijay ; Blanc, Jean-Frédéric ; Ellmark, Peter ; Pico de Coaña, Yago ; O'Reilly, Eileen M ; Borbath, Ivan ; Mitry, Emmanuel ; Smith, Karin Enell ; Pazo-Cid, Roberto Antonio ; Prenen, Hans ; Macarulla Mercade, Teresa ; Lambert, Aurélien ; Jimenez, David Gomez ; Beatty, Gregory L ; Rodriguez Garrote, Mercedes

Response determinants to immunotherapy in metastatic pancreatic ductal adenocarcinoma (mPDAC) remain unclear, limiting treatment advancements. We report a single-arm phase 1b/2 study (OPTIMIZE-1) evaluating the safety and efficacy of the cluster of differentiation 40 (CD40) agonist mitazalimab combined with modified FOLFIRINOX (mFOLFIRINOX), in chemotherapy-naive patients with mPDAC. Patients receive an initial dose of mitazalimab one week before starting biweekly cycles of mFOLFIRINOX plus mitazalimab. The study meets its pre-specified primary endpoint, achieving a confirmed objective response rate (ORR) of 42.1%. Median duration of response, progression-free survival, and overall survival was 12.6 months, 7.7 months, and 14.9 months, respectively. Multi-omic analyses of tumor and blood specimens identify a baseline tumor-intrinsic gene signature related to fibrosis associated with improved survival. Additionally, mitazalimab-induced increases in activated circulating myeloid, B cell, and T cell frequencies correlate with better outcomes. These results may inform future patient stratification strategies supporting a planned randomized confirmatory trial of mitazalimab with mFOLFIRINOX in mPDAC. This study was registered at ClinicalTrials.gov (NCT04888312).

01 Jul 2024·LANCET ONCOLOGY

Combining CD40 agonist mitazalimab with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (OPTIMIZE-1): a single-arm, multicentre phase 1b/2 study

Article

Author: Batlle, Jaime Feliu ; Prenen, Hans ; Cassier, Philippe Alexandre ; Pilla, Lorenzo ; Gallego, Inmaculada ; Pazo-Cid, Roberto Antonio ; Blanc, Jean-Frédéric ; Garrote, Mercedes Rodriguez ; Van Laethem, Jean-Luc ; Borbath, Ivan ; Pico de Coaña, Yago ; Ellmark, Peter ; Smith, Karin Enell ; Mitry, Emmanuel ; Ambarkhane, Sumeet Vijay ; Macarulla, Teresa ; Geboes, Karen Paula ; Lambert, Aurélien

BACKGROUND:

Current systemic therapies for metastatic pancreatic ductal adenocarcinoma are associated with poor outcomes with a 5-year overall survival rate under 5%. We aimed to assess the safety and antitumour activity of mitazalimab, a human CD40 agonistic IgG1 antibody, with modified FOLFIRINOX (mFOLFIRINOX; fluorouracil, leucovorin, oxaliplatin, and irinotecan), in chemotherapy-naive patients with metastatic pancreatic ductal adenocarcinoma.

METHODS:

OPTIMIZE-1 was a single-arm, multicentre, phase 1b/2 study which enrolled adults with histologically-confirmed metastatic pancreatic ductal adenocarcinoma and European Cooperative Oncology Group performance status 0 or 1 in 14 university hospitals in Belgium, France, and Spain. The primary endpoint of phase 1b was to determine the recommended phase 2 dose of intravenous mitazalimab (450 μg/kg or 900 μg/kg) when combined with intravenous mFOLFIRINOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², irinotecan 150 mg/m², fluorouracil 2400 mg/m²). In the first 21-day treatment cycle, mitazalimab was administered on days 1 and 10, and mFOLFIRINOX on day 8. In subsequent 14-day cycles mitazalimab was administered 2 days after mFOLFIRINOX. The phase 2 primary endpoint was objective response rate. Activity and safety analyses were conducted on the full analysis set (all patients who received the combination of mitazalimab at the recommended phase 2 dose and mFOLFIRINOX for at least two treatment cycles) and safety set (all patients who received any study treatment), respectively. Enrolment is complete, and data represents a primary analysis of the ongoing trial. The trial is registered at Clinicaltrials.gov (NCT04888312).

FINDINGS:

Between Sept 29, 2021, and March 28, 2023, 88 patients were screened and 70 patients were enrolled (40 [57%] were female and 30 [43%] were male). In phase 1b, 900 μg/kg mitazalimab was determined as the recommended phase 2 dose. Overall, five patients received 450 μg/kg mitazalimab; 65 received 900 μg/kg mitazalimab. No dose-limiting toxicities were observed at 450 μg/kg, and one dose-limiting toxicity was observed at 900 μg/kg. 57 patients were evaluated for activity, and all 70 patients were included in the safety set. At data cutoff on Nov 14, 2023, median follow-up was 12·7 months (95% CI 11·1-15·7). Of the 57 patients, 29 (51%) remained on study and 18 (32%) remained on treatment. The primary endpoint (objective response rate >30%) was met (objective response rates in 23 [40%]; one-sided 90% CI ≥32 of 57 patients). The most common grade 3 or worse adverse events were neutropenia (18 [26%] of 70 patients), hypokalaemia (11 patients [16%]), and anaemia and thrombocytopenia (eight patients [11%]). Serious adverse events were reported in 29 (41%) of 70 patients, the most common being vomiting (five [7%] of 70 patients), decreased appetite (four [6%]), and diarrhoea and cholangitis (three [4%] of 70 patients for each), none considered related to mitazalimab. No treatment-related deaths were reported.

INTERPRETATION:

Mitazalimab with mFOLFIRINOX demonstrated manageable safety and encouraging activity, warranting continued development in a phase 3, randomised, controlled trial. The results from OPTIMIZE-1 pave the way for further exploration and confirmation of a novel immunotherapy treatment regimen for metastatic pancreatic ductal adenocarcinoma, which is a complex and aggressive cancer with very low survival rates and restricted treatment options.

FUNDING:

Alligator Bioscience.

01 Feb 2024·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

Author: Richmond, Ann ; Yan, Chi ; Zhou, Yang

CD40 is a member of the tumor necrosis factor (TNF) receptor superfamily of receptors expressed on a variety of cell types. The CD40-CD40L interaction gives rise to many immune events, including the licensing of dendritic cells to activate CD8⁺ effector T cells, as well as the facilitation of B cell activation, proliferation, and differentiation. In malignant cells, the expression of CD40 varies among cancer types, mediating cellular proliferation, apoptosis, survival and the secretion of cytokines and chemokines. Agonistic human anti-CD40 antibodies are emerging as an option for cancer treatment, and early-phase clinical trials explored its monotherapy or combination with radiotherapy, chemotherapy, immune checkpoint blockade, and other immunomodulatory approaches. In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.

News (Medical) associated with Mitazalimab

12 Feb 2026

·www.biospace.com

Alligator Bioscience AB Reports Full Year Financial Results for 2025 and for Q4 2025 and Provides a Business Update

Rights issue completed: Approximately SEK 91 million (gross) raised in December, strengthening financial position with additional warrant upside in 2026. Mitazalimab validation: OPTIMIZE-1 biomarker results published in Cell Reports Medicine and REACtiVe-2 data in Nature Communications. Pipeline progress: U.S. patent granted for ATOR-4066, supporting long-term value beyond the lead program. LUND, SE / ACCESS Newswire / February 12, 2026 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced its interim results for the third quarter of 2025 and provided a business update. "The fourth quarter of 2025 was marked by continued execution on our strategy, focusing on advancing mitazalimab towards initiation of registrational trials, strengthening the scientific foundation of our pipeline, and increasing financial flexibility. While the external funding environment for biotech remains challenging, we have concentrated on areas within our control - generating high-quality data, maintaining operational discipline, and making focused investments that position the company to progress mitazalimab toward late-stage development." Søren Bregenholt, CEO of Alligator Bioscience BUSINESS UPDATE Mitazalimab Scientific validation: Biomarker analyses from OPTIMIZE-1 were published in Cell Reports Medicine , deepening the understanding of mitazalimab's mechanism of action and links to clinical outcomes. Additional clinical publication: Data from the Phase 1 REACtiVe-2 study were published in Nature Communications , supporting mitazalimab's ability to activate systemic immune responses in metastatic pancreatic cancer. External visibility: Mitazalimab data were presented at international scientific congresses during the quarter, further strengthening clinical relevance and scientific recognition. ATOR-4066 Pipeline progress: Preclinical and mechanistic data for ATOR-4066 were presented at international scientific meetings, supporting its immune-modulating potential as a next-generation bispecific antibody program. Strengthened intellectual property: A U.S. patent covering ATOR-4066 was granted, reinforcing long-term protection and supporting the program's future value. HLX22 Program expansion: Henlius received approval to initiate Phase 2/3 studies in breast cancer in China, broadening the clinical scope of HLX22 and potentially increasing the opportunity for future milestone payments and royalty revenues for Alligator. Company / Financial position Rights issue completed: Alligator finalized a rights issue of units (shares and warrants) to strengthen its financial position and support continued development of mitazalimab. Outcome announced 22 December: The issue was subscribed to approximately 64.8%, providing around SEK 91 million (gross) before issue costs and repayments. Additional capital potential in 2026: The rights issue included warrants that may provide further funding next year, supporting continued flexibility. Bridge financing and loan repayment: The rights issue followed bridge financing to secure near-term liquidity and enabled repayment of bridge loans and part of the outstanding loan to Fenja Capital. FINANCIAL SUMMARY FOR Q4 AND YEAR-END 2025 The financial summaries for the quarterly periods ending 31 December 2025 and 31 December 2024 are presented below. All amounts in MSEK, unless specified October - December 2025 October - December 2024 Net sales - 41.8 Operating profit/loss -22.5 -60.1 Profit/loss for the period -29.0 -55.4 Cash flow for the period 37.2 17.1 Cash and cash equivalents 62.2 64.3 Earnings per share before and after dilution*, SEK -0.66 -73.10 * Adjusted for reverse share split. The financial summaries for the year-to-date periods ending 31 December 2025 and 31 December 2024 are presented below. All amounts in MSEK, unless specified January - December 2025 January - December 2024 Net sales 0.5 57.8 Operating profit/loss -105.8 -229.1 Profit/loss for the period -51.4 -233.9 Cash flow for the period -1.2 -1.2 Cash and cash equivalents 62.2 64.3 Earnings per share before and after dilution*, SEK -1.87 -318.53 * Adjusted for reverse share split. The full report is attached as a PDF, and is also available on the company's website: Alligator will host a webinar on Thursday, 12 February 2026, at 3 p.m. CEST/ 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the interim report, which will be followed by a Q&A session. The call will be held in English. Attendees need to register by following >>this link<< . For further information, please contact: Søren Bregenholt, CEO E-mail: soren.bregenholt@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 Johan Giléus, CFO E-mail: johan.gileus@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CET on 12 February 2026. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab is currently ready for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com . Attachments 2025 Q4 EN VF SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

Phase 2ImmunotherapyPhase 1Financial StatementPhase 3

09 Jan 2026

·www.biospace.com

Alligator Bioscience to Present New OPTIMIZE-1 Data on Mitazalimab at ASCO Gastrointestinal Cancers Symposium 2026

LUND, SE / ACCESS Newswire / January 9, 2026 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announced that new data from its Phase 1b/2 OPTIMIZE-1 study evaluating mitazalimab in combination with mFOLFIRINOX in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC) will be presented at the ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA, taking place 8-11 January 2026. The presentation will highlight new analyses from OPTIMIZE-1 further characterizing the clinical benefit observed with mitazalimab plus standard chemotherapy in metastatic pancreatic cancer. The data support Alligator's continued preparations for mitazalimab's pivotal development and reinforce the scientific and clinical rationale for CD40 agonism as an immunotherapy approach in this hard-to-treat disease. Presentation details Title: CD40 agonist mitazalimab + mFOLFIRINOX (mFFX) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Final efficacy analysis of the OPTIMIZE-1 study. Abstract number: 708 Session/Time: Friday, 9 January 2026, 11:30 - 1:00 pm PST ; poster board J4 Presenter: Teresa Macarulla, Dept. of Medical Oncology, Vall d´Hebrón University Hospital, Vall d´Hebrón Institute of Oncology (VHIO), Barcelona, Spain "The OPTIMIZE-1 program continues to deliver compelling data supporting the potential of mitazalimab in metastatic pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience . "ASCO GI is one of the most important meetings for gastrointestinal oncology, bringing together leading clinicians and decision-makers in the field. We look forward to sharing these new analyses and to discuss the continued development of mitazalimab with key opinion leaders and clinical advisors." The accepted abstract is available at . For further information, please contact: Søren Bregenholt, CEO E-mail: soren.bregenholt@alligatorbioscience.com Phone: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 8:45 a.m. CET on 9 January 2026. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab is currently ready for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com . Attachments Alligator Bioscience to present new OPTIMIZE-1 data on mitazalimab at ASCO Gastrointestinal Cancers Symposium 2026 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

Clinical ResultImmunotherapyPhase 2Phase 3ASCO

17 Dec 2024

·www.businesswire.com

CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight Report 2025 - First CD40 Targeted Therapy Approval Expected By 2027 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025" report has been added to ResearchAndMarkets.com's offering. CD40 targeted therapies have become a focal point in immunotherapy research, with growing attention on harnessing the potential of the CD40 receptor to treat a variety of diseases. While no CD40 targeted therapies have yet been approved for clinical use, some promising candidates are currently undergoing late stage clinical development. Moreover, additional candidates are slated to enter late-stage trials within the next year, expanding the pool of CD40 targeted therapies in clinical development. These ongoing research and clinical trials suggest that CD40 targeted therapies could become a vital treatment option for patients with prevalent diseases in the coming years. Global CD40 Targeted Therapies Clinical Trials, Therapeutic Approaches & Market Opportunity Insight 2025 Report Highlights: First CD40 Targeted Therapy Approval Expected By 2027 CD40 Targeted Therapies In Clinical Trials: > 20 Therapies CD40 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase CD40 Targeted Therapy Research & Development Trends By Indication CD40 Targeted Therapy Market Trend Analysis By Region CD40 Targeted Therapies Proprietary Technologies By Company Historically, the primary focus of CD40 targeted therapies has been on autoimmune and inflammatory diseases. However, there is an increasing interest in exploring their potential for treating cancer and other conditions. More recent studies have expanded the scope of CD40 targeting to include infectious diseases, such as HIV and COVID-19, as well as neurodegenerative diseases like Alzheimer's and Parkinson's disease. Some research has also suggested that CD40 targeted therapies might be beneficial for diseases like cardiovascular conditions, where CD40's signaling pathway, although not directly involved in disease initiation, plays a role in disease progression and inflammation. Over the years, various strategies have been employed to target the CD40 receptor and its ligand. These include traditional monoclonal antibodies as well as next-generation molecular therapeutics such as small interfering RNA (siRNA). While antibodies are developed either as CD40 agonists or as antagonists, CD40 targeted siRNAs aim to reduce CD40 protein expression by degrading CD40 mRNA. Several other conventional and next-generation approaches are undergoing active research and clinical trials to assess their safety and efficacy. Nonetheless, antibody therapies remain the dominant approach in CD40 targeted research. Among the most advanced CD40/CD40L targeted antibodies are those for autoimmune and inflammatory diseases, with some entering phase 3 clinical trials. For example, Sanofi's Frexalimab, a promising anti CD40 antibody, is currently in phase 3 trials for autoimmune conditions. In the cancer domain, CD40 targeted antibodies are also making significant strides, with companies like Alligator Bioscience preparing to initiate phase 3 clinical trials for its lead candidate, mitazalimab, an anti-CD40 antibody for pancreatic ductal adenocarcinoma (PDA) and pancreatic cancer. The development of CD40 targeted therapies has been greatly facilitated by the advent of proprietary technologies and platforms. One notable example is GenMab's DuoBody platform, which enables the creation of bispecific antibodies that can target two different antigens simultaneously. This technology has been leveraged to develop several promising immunotherapies, including its CD40 targeted therapy, GEN1042/BNT312, currently in phase 2 trial for malignant solid tumors. As the field of CD40 targeted therapies evolves, the competitive landscape is becoming increasingly crowded, with many major pharmaceutical companies entering the arena. Notable players include Amgen, Sanofi, GenMab, BioNTech, and Biogen, all of which are investing heavily in this space. Collaborations between pharmaceutical companies and academic institutions have been essential in advancing the scientific understanding of CD40 targeted therapies, combining cutting edge research with clinical expertise to bring these therapies closer to market. In conclusion, while CD40 targeted therapies have not yet been approved for clinical use, they represent a promising and rapidly developing area of research across a wide range of diseases. As more therapies enter clinical trials and the competitive landscape intensifies, it is clear that CD40 targeted therapies could become a cornerstone of treatment for cancer, autoimmune diseases, infectious diseases, and beyond in the near future. Key Topics Covered: Introduction To CD40 Targeted Therapies Considering CD40 As Drug Target Over Other CD Markers History & Evolution Of CD40 Targeting Therapies CD40 Targeted Therapies - Mechanism Of Action Agonist Mediated Activation Of CD40 Signaling Antagonist-Mediated Inhibition Of CD40 Signaling CD40 Targeted Therapeutic Approaches Antibody Formats Fusion Proteins Peptides Nucleic Acids CD40 Targeted Therapy Research & Development Trends By Indication Cancer Neurological Diseases Autoimmune & Inflammatory Disorders Transplant Rejection Microbial Infections Global CD40 Targeted Therapy Market Outlook Current Market Trends & Developments Future Market Opportunities CD40 Targeted Therapy Market Trend Analysis By Region US Europe China Japan Australia CD40 Targeted Therapies Clinical Trials Insight By Company, Country, Indication & Phase Research Preclinical Phase I Phase I/II Phase II Phase III CD40 Targeted Therapies - Proprietary Technologies By Company Alligator Bioscience - FIND Technology & Neo-X-Prime Aprilbio - SAFA Platform Biocytogen - RenMice EnnoDC - Unnamed Platform Genmab - DuoBody Harbour BioMed - Harbour Mice & HBICE Kyowa Kirin - REGULGENT Strike Pharma - ADAC Technology Platform Global CD40 Targeted Therapy Market Dynamics Competitive Landscape Alligator Bioscience Amgen Biogen BioNTech Eledon Pharmaceuticals EnnoDC Genmab Innovent Bio Novartis Sanofi Tonix Pharmaceuticals UCB For more information about this report visit https://www.researchandmarkets.com/r/46sm5e About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

ImmunotherapyPhase 3Phase 2

100 Deals associated with Mitazalimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15225

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic carcinoma non-resectable	Phase 2	United States	University of Pennsylvania	25 Nov 2025
Pancreatic Ductal Adenocarcinoma	Phase 2	United States	University of Pennsylvania	25 Nov 2025
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	France	Alligator Bioscience AB	25 Feb 2021
Breast Cancer	Phase 1	-	Alligator Bioscience AB	01 Mar 2026
Advanced Malignant Solid Neoplasm	Phase 1	Denmark	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	Sweden	Alligator Bioscience AB	01 Apr 2015
Advanced Malignant Solid Neoplasm	Phase 1	United Kingdom	Alligator Bioscience AB	01 Apr 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


OPTIMIZE-1 (SITC2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	94	Mitazalimab 450 μg/kg + mFOLFIRINOX	buonfbzihr(gtapnexlal) = lncwfexrko snzapodwou (bndgvtqiwz ) View more	Positive	05 Nov 2025
OPTIMIZE-1 (SITC2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	94	Mitazalimab 900 μg/kg + mFOLFIRINOX	buonfbzihr(gtapnexlal) = ebhtsfokob snzapodwou (bndgvtqiwz ) View more	Positive	05 Nov 2025
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	79	Mitazalimab 450 µg/kg + mFOLFIRINOX	mbsiwgjiot(jxzhmhshxm) = zfrjlwxcwg wgyxbswlgs (agapeduxnl ) View more	Positive	03 Jul 2025
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	79	Mitazalimab 900 µg/kg + mFOLFIRINOX	dzuriaqrdc(cufjzzvhnl) = akltunnvwt xqyldjtmks (ygcwjofbbg, 42.1% confirmed)	Positive	03 Jul 2025
NCT04888312 (OPTIMIZE-1, ASCO2025)	Phase 1/2	Metastatic Pancreatic Cancer RNAseq data from tumor biopsies \| circulating tumor KRAS (ctKRAS)	57	Mitazalimab + mFOLFIRINOX	dirfmszutw(vxubmctjhr) = liubxvkrxo jadznjnsqd (hnynpuzcow ) View more	Positive	30 May 2025
NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	MITAZALIMAB + mFOLFIRINOX	jgsbmuilxe(hxcdqvlcol) = wdqqtdaozk vactukayfv (rxpwahougs ) View more	Positive	26 Feb 2025
NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mFOLFIRINOX	jgsbmuilxe(hxcdqvlcol) = mizqaftpps vactukayfv (rxpwahougs ) View more	Positive	26 Feb 2025
OPTIMIZE-1 (SITC2024)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma MCP-1 \| IFN-Î³	57	Mitazalimab 900 Âµg/kg	cdhzwhgsfq(sxxyxbzsra) = slyzidmwmb vpfqruhmqz (yvfjtmpuzp ) View more	Positive	05 Nov 2024
NCT04888312 (OPTIMIZE-1, Pubmed \| Lancet Oncol)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	70	Mitazalimab 900 μg/kg	kbbfgkiihq(aqskvkvkgu) = eight patients [11%] lxgdyzjzlh (yrarswnwla ) View more	Positive	01 Jul 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line KRAS G12D \| KRAS G12R \| KRAS G12V	57	Mitazalimab + mFOLFIRINOX	uppwhlzqyo(przqdvpjxz) = lipaxvughb baeglcfzvk (ysaijfkztz, 29.4 - 52.1) View more	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mitazalimab+FOLFIRINOX	jqqrctmjkh(rdltszjmyp) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. ntjouhxddf (afxfeuuyzg )	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, PRNewswire) Manual	Phase 2	Pancreatic Cancer First line	57	Mitazalimab	mflbpltjfx(upxxuugmrk) = rrxicwtgsv lnpmwflijs (pderygvvad ) View more	Positive	01 Jul 2023
NCT04888312 (OPTIMIZE-1, ASCO2023) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	43	Mitazalimab + mFOLFIRINOX	conuuhtrnd(nmxknysbbg) = cdjnpcvfas wpcatwprto (scuxumudzg ) View more	Positive	31 May 2023

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