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    DRUG:

    magrolimab (ONO-7913)

    i
    Other names: ONO-7913, GS-4721, Hu5F9 G4, Hu5F9G4, 5F9, Hu5F9-G4, GS 4721, GS4721, ONO 7913, ONO7913
    Company:
    Gilead, Ono Pharma
    Drug class:
    CD47 inhibitor
    Related drugs:
    1m
    An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: May 2025 --> Dec 2026 | Trial primary completion date: May 2025 --> Dec 2026
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
    2ms
    Impact of Mutational Landscape and CD47 Levels in the Magrolimab + Azacitidine Vs Placebo + Azacitidine Trial in Patients with Untreated Higher Risk Myelodysplastic Syndrome (ASH 2024)
    Given the imbalanced cytogenetic risk between CD47 high and CD47 low in the magrolimab+ aza arm, the observation warrants further investigation into the connection between cytogenetic risk, CD47 levels, and CD47 blockade. Additional data with respect to the mutational landscape will be forthcoming, including central evaluation of TP53 status.
    Clinical
    |
    TP53 (Tumor protein P53) • CD47 (CD47 Molecule) • CALR (Calreticulin) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TP53 mutation • CD47 overexpression
    |
    TruSight Oncology 500 Assay
    |
    azacitidine • magrolimab (ONO-7913)
    2ms
    ELEVATE TNBC: Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=92, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Sponsor decision to terminate study.
    Trial termination • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • magrolimab (ONO-7913)
    2ms
    ELEVATELung&UC: Study of Magrolimab in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=106, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Sponsor decision to terminate study
    Trial termination
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    docetaxel • magrolimab (ONO-7913)
    2ms
    ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=193, Terminated, Gilead Sciences | Trial completion date: Jul 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Oct 2024; Sponsor decision to terminate study
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (ONO-7913)
    2ms
    PNOC025: Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors (clinicaltrials.gov)
    P1, N=13, Completed, University of California, San Francisco | Suspended --> Completed | N=24 --> 13 | Trial completion date: Feb 2025 --> Sep 2024 | Trial primary completion date: Feb 2025 --> Sep 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    magrolimab (ONO-7913)
    3ms
    GS-US-546-5920: Study of Magrolimab Combinations in Participants With Myeloid Malignancies (clinicaltrials.gov)
    P2, N=54, Completed, Gilead Sciences | Trial primary completion date: Oct 2023 --> Mar 2024
    Trial primary completion date
    |
    Venclexta (venetoclax) • cytarabine • etoposide IV • mitoxantrone • magrolimab (ONO-7913) • Onureg (azacitidine oral)
    3ms
    Biomarker analysis of magrolimab plus docetaxel in patients with 2L+ mNSCLC from ELEVATE-Lung and UC, a phase 2 multicohort study (SITC 2024)
    All authors had full access to the data and vouched for the completeness and accuracy of the data and analyses, and adherence of the study to the protocol (online only). Consent All patients provided written informed consent before study entry.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD47 (CD47 Molecule) • CD80 (CD80 Molecule) • CD86 (CD86 Molecule)
    |
    CD47 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    docetaxel • magrolimab (ONO-7913)
    3ms
    ASTX727-10: A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS) (clinicaltrials.gov)
    P2, N=2, Terminated, Astex Pharmaceuticals, Inc. | N=100 --> 2
    Enrollment change
    |
    Inqovi (decitabine/cedazuridine) • magrolimab (ONO-7913)
    3ms
    Managing the unmanageable: evidence-driven approaches to real-world patient prototypes of TP53-mutant myelodysplastic neoplasms and acute myeloid leukemia. (PubMed, Leukemia)
    The debate regarding whether allogeneic stem cell transplant should be offered to these patients is summarized. Finally, this review explores the recent unfortunate news of pauses in clinical trials for the leading investigational agents - eprenetapopt, magrolimab, sabatolimab, and idasanutlin - and offers solutions toward re-invigorating the pipeline of precision therapeutics in 2025.
    Review • Journal • Real-world evidence • Real-world
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    eprenetapopt (APR-246) • idasanutlin (RG7388) • magrolimab (ONO-7913) • sabatolimab (MBG453)
    3ms
    MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
    P1/2, N=645, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> May 2026
    Enrollment closed • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
    3ms
    ONO-7913-04: The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer (clinicaltrials.gov)
    P1, N=65, Active, not recruiting, Ono Pharmaceutical Co. Ltd | Trial completion date: Jan 2025 --> Dec 2027 | Trial primary completion date: Jan 2025 --> Dec 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
    3ms
    ELEVATE TNBC: Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P2, N=92, Active, not recruiting, Gilead Sciences | Trial completion date: Jan 2025 --> Oct 2024
    Trial completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 negative
    |
    albumin-bound paclitaxel • Trodelvy (sacituzumab govitecan-hziy) • magrolimab (ONO-7913)
    3ms
    Magrolimab in Combination with Azacitidine After Allogeneic HCTin Treating Patients with High-Risk AML or MDS (clinicaltrials.gov)
    P1, N=0, Withdrawn, City of Hope Medical Center | N=44 --> 0 | Trial completion date: May 2025 --> Feb 2026 | Suspended --> Withdrawn | Trial primary completion date: May 2025 --> Feb 2026
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy • Post-transplantation
    |
    azacitidine • magrolimab (ONO-7913)
    3ms
    ELEVATELung&UC: Study of Magrolimab in Patients With Solid Tumors (clinicaltrials.gov)
    P2, N=106, Active, not recruiting, Gilead Sciences | Trial completion date: Mar 2025 --> Oct 2024
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    docetaxel • magrolimab (ONO-7913)
    3ms
    Circumventing resistance within the Ewing sarcoma microenvironment by combinatorial innate immunotherapy. (PubMed, J Immunother Cancer)
    Our preclinical studies demonstrate that immunotherapy via the innate immune system by combining tumor-targeting CAR-NK cells with an IL-15 agonist and a CD47 blockade is a promising novel therapeutic approach to targeting MCAMhigh malignant metastatic ES.
    Journal • IO biomarker
    |
    IFNG (Interferon, gamma) • MCAM (Melanoma Cell Adhesion Molecule) • IL15 (Interleukin 15)
    |
    MCAM expression
    |
    magrolimab (ONO-7913) • avipendekin pegol (NKTR-255)
    4ms
    Phase II Trial of Magrolimab and Cetuximab with Pembrolizumab or Docetaxel for Recurrent/metastatic Head Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=4, Terminated, M.D. Anderson Cancer Center | N=57 --> 4 | Trial completion date: Nov 2029 --> Aug 2024 | Suspended --> Terminated | Trial primary completion date: Nov 2027 --> Aug 2024; Slow Accrual
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • docetaxel • magrolimab (ONO-7913)
    5ms
    The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer (clinicaltrials.gov)
    P1, N=65, Active, not recruiting, Ono Pharmaceutical Co. Ltd
    New P1 trial • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • oxaliplatin • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
    5ms
    An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Ono Pharmaceutical Co. Ltd
    New P1 trial • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • oxaliplatin • irinotecan • leucovorin calcium • magrolimab (ONO-7913) • levoleucovorin calcium
    5ms
    Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies (clinicaltrials.gov)
    P1, N=1, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Feb 2027 --> Jun 2024
    Trial completion • Trial completion date
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
    |
    Venclexta (venetoclax) • Gazyva (obinutuzumab) • magrolimab (ONO-7913)
    5ms
    Targeting the CD47/SIRPα pathway in malignancies: recent progress, difficulties and future perspectives. (PubMed, Front Oncol)
    However, a series of setbacks unfolded recently, starting with the July 2023 announcement of discontinuing the phase 3 ENHANCE study on Magrolimab plus Azacitidine for higher-risk myelodysplastic syndromes (MDS). Subsequently, in August 2023, the termination of the ASPEN-02 program, assessing Evorpacept in combination with Azacitidine in MDS patients, was disclosed due to insufficient improvement compared to Azacitidine alone. These setbacks have cast doubt on the feasibility of targeting CD47 in the industry. In this review, we delve into the challenges of developing CD47-SIRPα-targeted drugs, analyze factors contributing to the mentioned setbacks, discuss future perspectives, and explore potential solutions for enhancing CD47-SIRPα-targeted drug development.
    Review • Journal
    |
    PD-1 (Programmed cell death 1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    azacitidine • magrolimab (ONO-7913) • evorpacept (ALX148)
    5ms
    ELEVATE CRC: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P2, N=77, Terminated, Gilead Sciences | N=135 --> 77 | Trial completion date: Nov 2026 --> Jun 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2025 --> Jun 2024; Sponsor decision to terminate study
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • magrolimab (ONO-7913)
    5ms
    Combinatorial macrophage induced innate immunotherapy against Ewing sarcoma: Turning "Two Keys" simultaneously. (PubMed, J Exp Clin Cancer Res)
    By turning "two keys" simultaneously to reactivate macrophage phagocytic activity, our data demonstrated an effective and highly translatable alternative therapeutic approach utilizing innate (tumor associated macrophages) immunotherapy against high-risk metastatic ES.
    Journal • IO biomarker
    |
    CD38 (CD38 Molecule) • CD47 (CD47 Molecule) • CD163 (CD163 Molecule) • CSF2 (Colony stimulating factor 2) • CALR (Calreticulin) • MRC1 (Mannose Receptor C-Type 1) • ANXA5 (Annexin A5)
    |
    doxorubicin hydrochloride • magrolimab (ONO-7913)
    6ms
    MACOCUC-01: Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Insel Gruppe AG, University Hospital Bern | N=26 --> 0 | Trial completion date: Aug 2028 --> Feb 2024 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2028 --> Feb 2024
    Enrollment change • Trial completion date • Trial withdrawal • Trial primary completion date • Combination therapy • Metastases
    |
    cisplatin • gemcitabine • magrolimab (ONO-7913)
    6ms
    Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=8, Active, not recruiting, Stanford University | Suspended --> Active, not recruiting | N=24 --> 8
    Enrollment closed • Enrollment change
    |
    Keytruda (pembrolizumab) • magrolimab (ONO-7913)
    7ms
    Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment (clinicaltrials.gov)
    P1/2, N=88, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Dec 2025 --> Jun 2025
    Trial completion date • Trial primary completion date • Combination therapy • Immune cell
    |
    Poteligeo (mogamulizumab-kpkc) • magrolimab (ONO-7913)
    7ms
    Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=24, Suspended, Stanford University | Recruiting --> Suspended
    Trial suspension
    |
    Keytruda (pembrolizumab) • magrolimab (ONO-7913)
    7ms
    Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1/2, N=178, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Study terminated early due to the magrolimab program discontinuation.
    Trial termination
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • magrolimab (ONO-7913)
    7ms
    TP53 Mutations in Acute Leukemias and Myelodysplastic Syndromes: Insights and Treatment Updates. (PubMed, Am Soc Clin Oncol Educ Book)
    The most heavily investigated and targeted agent for patients with TP53-mutant MDS and AML has been APR-246 (eprenetapopt) a p53 reactivator, in combination with azacitidine, but also in triplets with venetoclax...Other agents, like magrolimab (anti-CD47 antibody), failed to demonstrate improved activity in TP53-mutant MDS and AML...Delivering prognostic information in a dismal disease like TP53-mutated MDS and AML is particularly challenging. The physician should balance hope and realism, describing the trajectory of possible treatments and at the same time indicating the poor outcome, together with promoting adaptive coping in patients and elaborating on the nature of the disease.
    Review • Journal
    |
    TP53 (Tumor protein P53) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • eprenetapopt (APR-246) • magrolimab (ONO-7913)
    7ms
    Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov)
    P2, N=35, Completed, Gilead Sciences | Active, not recruiting --> Completed | N=153 --> 35 | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    bortezomib • Darzalex (daratumumab) • carfilzomib • dexamethasone • pomalidomide • magrolimab (ONO-7913)
    8ms
    Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations (clinicaltrials.gov)
    P1, N=0, Withdrawn, National Cancer Institute (NCI) | N=33 --> 0 | Suspended --> Withdrawn
    Enrollment change • Trial withdrawal • Combination therapy • Metastases
    |
    IFNG (Interferon, gamma) • CD47 (CD47 Molecule) • BRCA (Breast cancer early onset) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • TGFB1 (Transforming Growth Factor Beta 1) • IRF3 (Interferon Regulatory Factor 3)
    |
    HR positive • BRCA mutation • CD47 expression
    |
    Lynparza (olaparib) • magrolimab (ONO-7913)
    8ms
    Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (clinicaltrials.gov)
    P1, N=82, Active, not recruiting, National Cancer Institute (NCI) | Suspended --> Active, not recruiting
    Enrollment closed
    |
    magrolimab (ONO-7913) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    8ms
    ENHANCE-3: Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (clinicaltrials.gov)
    P3, N=378, Terminated, Gilead Sciences | Trial completion date: Jul 2025 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Apr 2024; Study was terminated due to futility
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • magrolimab (ONO-7913)
    8ms
    ENHANCE-2: Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated (clinicaltrials.gov)
    P3, N=258, Terminated, Gilead Sciences | Active, not recruiting --> Terminated; Study discontinued due to futility.
    Trial termination • Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • daunorubicin • idarubicin hydrochloride • magrolimab (ONO-7913)
    9ms
    A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants (clinicaltrials.gov)
    P1/2, N=0, Withdrawn, Novartis Pharmaceuticals | N=63 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    azacitidine • magrolimab (ONO-7913) • sabatolimab (MBG453)
    9ms
    Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy (clinicaltrials.gov)
    P1, N=34, Completed, Gilead Sciences | Phase classification: P1b --> P1
    Phase classification • Combination therapy • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Bavencio (avelumab) • magrolimab (ONO-7913)
    9ms
    Study of Magrolimab Combinations in Participants With Myeloid Malignancies (clinicaltrials.gov)
    P2, N=54, Completed, Gilead Sciences | Active, not recruiting --> Completed
    Trial completion
    |
    Venclexta (venetoclax) • cytarabine • etoposide IV • mitoxantrone • magrolimab (ONO-7913) • Onureg (azacitidine oral)
    9ms
    Opportunities and challenges for anti-CD47 antibodies in hematological malignancies. (PubMed, Front Immunol)
    Bispecific antibodies and SIRPα/Fc fusion proteins appear to balance the efficacy and safety of treatment. We review the latest clinical research advances and discuss the opportunities and challenges associated with CD47-based immunotherapy for hematological malignancies.
    Review • Journal
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    magrolimab (ONO-7913)
    9ms
    ELEVATE CRC: Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC) (clinicaltrials.gov)
    P2, N=135, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    RAS wild-type
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • magrolimab (ONO-7913)
    10ms
    ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=230, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (ONO-7913)
    10ms
    Gentulizumab, a novel anti-CD47 antibody with potent antitumor activity and demonstrates a favorable safety profile. (PubMed, J Transl Med)
    GenSci059 selectively binds to CD47, effectively blocks the CD47/SIRPα axis signaling pathway and enhances the phagocytosis effects of macrophages toward tumor cells. This monoclonal antibody demonstrates potent antitumor activity and exhibits a favorable safety profile, positioning it as a promising and effective therapeutic option for cancer.
    Journal
    |
    SIRPA (Signal Regulatory Protein Alpha)
    |
    Rituxan (rituximab) • magrolimab (ONO-7913)
    10ms
    Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=57, Suspended, M.D. Anderson Cancer Center | Recruiting --> Suspended
    Trial suspension • Metastases
    |
    PD-L1 (Programmed death ligand 1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • docetaxel • magrolimab (ONO-7913)