The goal of this clinical trial is to etablish whether adding Mitazalimab to standard chemotherapy is more effective than standard chemotherapy alone in people with advanced bile duct cancer. It will also learn about the safety of Mitazalimab.
The main questions it aims to answer are:
* Does the addition of Mitazalimab enhance efficacy?
* What medical problems do participants have when taking Mitazalimab + mFOLFOX?
Participants will:
* Take drug mFOLFOX every two weeks until disease progression or mFOLFOX every two weeks plus mitazalimab in addition to mFOLFOX, with a first injection 7 days before the first mFOLFOX chemotherapy and then 3 days after the start of each mFOLFOX cycle.
* Visit the clinic once every 2 weeks for checkups and tests
* Have a radiological assessment every 8 weeks during treatment. After stopping treatment, participants will be monitored at the hospital every 8 weeks if no progression is observed, or every 12 weeks after disease progression.

Start Date01 Jul 2026

Sponsor / Collaborator

UNICANCER

[+1]

NCT07319195

/ RecruitingEarly Phase 1IIT

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 Date27 Apr 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 4-8 months of first line (1L) chemotherapy.

Start Date25 Nov 2025

Sponsor / Collaborator

University of Pennsylvania

[+1]

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

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: Yang Zhou ; Ann Richmond ; Chi Yan

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

02 Jul 2026

·www.biospace.com

Alligator Announces First Patient Dosed in Investigator-Initiated Study of Intratumoral Mitazalimab in Early-Stage Breast Cancer

LUND, SE / ACCESS Newswire / July 2, 2026 / Alligator Bioscience (STO:ATORX) First patient dosed in an investigator-initiated trial evaluating intratumoral mitazalimab, with or without intratumoral nivolumab Study evaluates how local CD40 activation affects the tumor microenvironment ahead of surgery to inform future clinical development Trial conducted at an Ivy League university in the United States Lund, Sweden - 2 July 2026 - Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, today announces that the first patient has been dosed in an investigator-initiated trial (IIT, NCT07319195 ) evaluating intratumoral administration of mitazalimab, Alligator's lead CD40 agonist, in patients with early-stage breast cancer. The study will evaluate mitazalimab given as a single intratumoral dose, either alone or in combination with a single intratumoral dose of the PD-1 inhibitor nivolumab, prior to surgery. While checkpoint inhibitors have improved outcomes in some breast cancer subtypes, there remains a need for more effective and better-tolerated immunotherapy approaches in others. In a recent publication in NPJ Breast Cancer , Dr Zhang has demonstrated that CD40 agonists synergize with PD-1 inhibitor in preclinical breast cancer models eradicating tumors and providing long lasting tumor immunity. This IIT will explore if local CD40 activation can enhance anti-tumor immunity in resectable breast cancer, and generate translational insights to guide further randomized trials. The primary endpoints are safety and feasibility of administering mitazalimab, with or without nivolumab, prior to surgery. Secondary and exploratory objectives include pathologic and imaging-based measures of anti-tumor activity and translational analyses intended to characterize immune activation in the tumor microenvironment. "We are pleased to support this investigator-initiated trial evaluating intratumoral mitazalimab in early-stage breast cancer. Breast cancer is the most common cancer in women, and the leading cause of cancer-related death. said Søren Bregenholt, CEO of Alligator Bioscience . As the biology and treatment of breast cancer varies significantly from that of pancreatic cancer this trial has the potential to generate valuable new translational insights that can guide future development to expand the clinical utility of mitazalimab." About investigator-initiated trials Investigator-initiated trials (IITs) are sponsored and executed by clinical investigators, with Alligator's consent, but without our direct involvement besides supplying mitazalimab, providing scientific input and ensuring certain aspects of clinical safety reporting. IITs offer the opportunity to strengthen our understanding of mitazalimab's mechanism of action, expand its potential use beyond pancreatic cancer, and explore additional indications to support further development. Alligator announces the initiation of an IIT once the first patient has been dosed with mitazalimab, and shares key outcomes and milestones, but does not commit to provide regular updates on individual trials. 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 10:30 a.m. CEST on 2 July 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 30-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 announces first patient dosed in investigator-initiated study of intratumoral mitazalimab in early-stage breast cancer SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

08 Jun 2026

·www.biospace.com

Alligator Bioscience Comments on Henlius Update on Global Phase 3 Trial with HLX22

LUND, SE / ACCESS Newswire / June 8, 2026 / Alligator Bioscience (STO:ATORX) today comments on a recent update regarding patient recruitment in the ongoing Phase 3 clinical trial of HLX22, developed by Shanghai Henlius Biotech, Inc. According to communication shared by Henlius, the first patients have now been dosed in all regions participating in the global Phase 3 study of HLX22, including China, Japan, Korea, Latin America, Australia, the United States and Europe. HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues. "The successful dosing of the first patients across all regions marks an important milestone, signaling the continued progress in the Phase 3 study with HLX22," said Søren Bregenholt, CEO of Alligator Bioscience . "The continued advancement also suggests sustained investigator interest in evaluating HLX22 as a potential treatment option for patients with gastric cancers." Under the terms of Alligator's agreement with AbClon, Alligator is entitled to 35% of AbClon's revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator. 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 08:45 a.m. CEST on 8 June 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 30-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 comments on Henlius update on global phase 3 trial with HLX22 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

Phase 3Clinical ResultOrphan DrugLicense out/inImmunotherapy

22 May 2026

·www.biospace.com

Alligator Bioscience Comments on Henlius Update on Long-Term Follow-Up Data for HLX22

LUND, SE / ACCESS Newswire / May 22, 2026 / Alligator Bioscience (Nasdaq Stockholm:ATORX) today comments on a recent update shared by Shanghai Henlius Biotech, Inc. regarding long-term follow-up observations from clinical studies of HLX22. According to Henlius' communication, long-term follow-up over more than 39 months indicates that patients treated with HLX22 continue to demonstrate extended progression-free survival (PFS) at the current observation point. The update reflects ongoing follow-up and does not include new numerical efficacy data. HLX22 is an innovative anti-HER2 monoclonal antibody that has been granted orphan drug designation in both the U.S. and EU for gastric cancer and is being developed by Henlius under a license from AbClon, Inc., following a discovery collaboration which grants Alligator the right to participate in potential future revenues. "We view Henlius' update on the long-term follow-up of HLX22 as further evidence of the continued clinical development of the program," said Søren Bregenholt, CEO of Alligator Bioscience . "Sustained follow-up across studies is an important part of building the overall understanding of a molecule's profile, and we note Henlius' ongoing efforts to advance HLX22 across multiple indications." Under the terms of Alligator's agreement with AbClon, Alligator is entitled to 35% of AbClon's revenue from its sublicense to Henlius, including potential milestone payments and royalty revenues, which, if HLX22 is successfully developed and approved, could represent a meaningful long-term revenue opportunity for Alligator. 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 08:15 a.m. CEST on 22 May 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 30-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 comments on Henlius update on long-term follow-up data for HLX22 SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire

Clinical ResultOrphan DrugPhase 2Phase 3License out/in

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
Advanced biliary tract cancer	Phase 3	France	Alligator Bioscience AB	01 Jul 2026
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	Belgium	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	France	Alligator Bioscience AB	17 Sep 2021
Metastatic Pancreatic Ductal Adenocarcinoma	Phase 2	Spain	Alligator Bioscience AB	17 Sep 2021
Solid tumor	Phase 2	-	Alligator Bioscience AB	-
Breast Cancer	Phase 1	United States	Alligator Bioscience AB	27 Apr 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

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	cylbgqxzcx(zpuuwwjdgt) = iecqwvsjyg voztuzfhlg (bioueyjpdx ) View more	Positive	05 Nov 2025
OPTIMIZE-1 (SITC2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	94	Mitazalimab 900 μg/kg + mFOLFIRINOX	cylbgqxzcx(zpuuwwjdgt) = zhnhkxgsch voztuzfhlg (bioueyjpdx ) View more	Positive	05 Nov 2025
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	79	Mitazalimab 450 µg/kg + mFOLFIRINOX	dqarqygtxt(ybfpfurzee) = hendrakcvc puamoxhicl (leqwnhhuzt ) View more	Positive	03 Jul 2025
NCT04888312 (OPTIMIZE-1, ESMO_GI2025)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	79	Mitazalimab 900 µg/kg + mFOLFIRINOX	myfxdvdlap(pmuhynjjqx) = cbxpiwznmf bifvczqsln (bulfsvxgnv, 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	fuyxsmukgl(zvphetmtoi) = pslngedrkv bzdykuyxyh (ygsfhudgzt ) View more	Positive	30 May 2025
NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	MITAZALIMAB + mFOLFIRINOX	bpksipemla(cpvdbdwvcm) = ljbxgolljc wuitmcisjp (ussyrswxmf ) View more	Positive	26 Feb 2025
NCT04888312 (OPTIMIZE-1, NEWS) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mFOLFIRINOX	bpksipemla(cpvdbdwvcm) = lqagkzccph wuitmcisjp (ussyrswxmf ) 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	xvmdvyjbox(vdevzhptwd) = ccgqckhztb njtjjylppf (hugdqeiczk ) View more	Positive	05 Nov 2024
NCT04888312 (OPTIMIZE-1, Pubmed \| Lancet Oncol)	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	70	Mitazalimab 900 μg/kg	ciynuwyymn(rncjxhprft) = eight patients [11%] ogrnsiukul (ghtazeiqse ) View more	Positive	01 Jul 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma First line	-	mitazalimab+FOLFIRINOX	gwuiecalrg(rnplenleik) = associated with an expansion in the frequency of effector CD4 T cells (p < 0.0001) at day 8 after receiving mitazalimab. lrbvksmzzj (qpphvqfydm )	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, ASCO2024) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line KRAS G12D \| KRAS G12R \| KRAS G12V	57	Mitazalimab + mFOLFIRINOX	dnzzroddra(grvgcnyohy) = jynavdqtzw oguycjkfwf (gccfzqbtlp, 29.4 - 52.1) View more	Positive	24 May 2024
NCT04888312 (OPTIMIZE-1, PRNewswire) Manual	Phase 2	Pancreatic Cancer First line	57	Mitazalimab	ivqyefkrlw(orgnfvvgpg) = larfhdxfsy ahpgoksiqf (swememjopc ) View more	Positive	01 Jul 2023
NCT04888312 (OPTIMIZE-1, ASCO2023) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma	43	Mitazalimab + mFOLFIRINOX	tdzpvwgoax(ddptipwzlg) = ljvswnysyq dkasiuapgx (pbmzosihwx ) View more	Positive	31 May 2023

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