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    DRUG CLASS:

    CD47 inhibitor

    Related drugs:
    17h
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    8d
    A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=7, Completed, Pfizer | Active, not recruiting --> Completed
    Trial completion
    |
    maplirpacept (TTI-622)
    8d
    A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Hematologic Malignancy (clinicaltrials.gov)
    P1, N=70, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | N=230 --> 70
    Trial completion • Enrollment change
    |
    simridarlimab (IBI-322)
    11d
    PREVLAR: Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (clinicaltrials.gov)
    P2, N=53, Completed, EpicentRx, Inc. | Phase classification: P2a --> P2
    Phase classification • Metastases
    |
    cisplatin • nibrozetone (RRx-001)
    14d
    Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, Pfizer | Phase classification: P1/2 --> P2
    Phase classification • Combination therapy
    |
    pegylated liposomal doxorubicin • maplirpacept (TTI-622)
    14d
    REPLATINUM: A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=292, Active, not recruiting, EpicentRx, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • etoposide IV • nibrozetone (RRx-001)
    15d
    CD47 and Calreticulin Expression in Breast Cancer Subtypes and Anti-CD47 Inhibitory Effects in Macrophage-mediated Phagocytosis. (PubMed, Anticancer Res)
    The expression profiles of CD47 and CALR in breast cancer subtypes and the benefit of CD47 blocking-based immunotherapy are herein provided.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule) • CALR (Calreticulin)
    16d
    IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=135, Suspended, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Recruiting --> Suspended | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 overexpression
    |
    IMM2902
    23d
    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)
    24d
    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)
    28d
    BAT7104 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=14, Completed, Bio-Thera Solutions | Active, not recruiting --> Completed | N=29 --> 14 | Trial completion date: Dec 2024 --> Jun 2024 | Trial primary completion date: Sep 2024 --> Jun 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    28d
    IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov)
    P3, N=170, Recruiting, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
    New P3 trial • Combination therapy
    |
    azacitidine • timdarpacept (IMM01)
    30d
    A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=9, Terminated, Celgene | Completed --> Terminated; Business objectives have changed.
    Trial termination
    1m
    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)
    1m
    Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=4, Active, not recruiting, Pfizer | Trial primary completion date: May 2025 --> Aug 2024
    Trial primary completion date
    |
    lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
    1m
    A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=280, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    ligufalimab (AK117)
    1m
    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)
    1m
    A Study of Dual-SIgnaling Protein 107 (DSP107) for Patients with Hematological Malignancies (clinicaltrials.gov)
    P1, N=36, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • azacitidine • DSP-107
    1m
    A Study to Learn About the Study Medicine (Called Maplirpacept (PF-07901801)) in Japanese With Hematologic Malignancies (clinicaltrials.gov)
    P1, N=7, Active, not recruiting, Pfizer | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
    Trial completion date • Trial primary completion date
    |
    maplirpacept (TTI-622)
    1m
    A Study of DSP107 Alone and in Combination with Atezolizumab for Patients with Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=125, Recruiting, Kahr Medical | Trial completion date: Dec 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • BRAF mutation • KRAS wild-type • RET mutation • RAS wild-type
    |
    Tecentriq (atezolizumab) • DSP-107
    1m
    DNp73 enhances tumor progression and immune evasion in multiple myeloma by targeting the MYC and MYCN pathways. (PubMed, Front Immunol)
    Blockade of the CD47/SIRPα and PD-1/PD-L1 signaling pathways by the SIRPα-Fc fusion protein IMM01 and monoclonal antibody atezolizumab significantly restored the anti-MM activity of macrophages and T cells in the microenvironment, respectively. Moreover, our study clarified that DNp73 overexpression not only promotes aggressive growth of tumor cells but, more importantly, promotes immune escape of MM cells through upregulation of immune checkpoints. DNp73 could serve as a biomarker for immunotherapy targeting PD-L1 and CD47 blockade in MM patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MYCN (MYCN Proto-Oncogene BHLH Transcription Factor) • CD47 (CD47 Molecule) • CDK7 (Cyclin Dependent Kinase 7) • SIRPA (Signal Regulatory Protein Alpha)
    |
    TP53 mutation • MYCN expression
    |
    Tecentriq (atezolizumab) • timdarpacept (IMM01)
    1m
    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)
    1m
    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.
    P2 data • Clinical • 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)
    1m
    SL03-OHD-105: Phase 1b Study of SL-172154 Administered with Combination Agent(s) in Subjects with Ovarian Cancers (clinicaltrials.gov)
    P1, N=86, Active, not recruiting, Shattuck Labs, Inc. | Trial completion date: Apr 2025 --> Nov 2024
    Trial completion date
    |
    FOLR1 ( Folate receptor alpha )
    |
    FOLR1 expression
    |
    pegylated liposomal doxorubicin • Elahere (mirvetuximab soravtansine-gynx) • SL-172154
    1m
    SL03-OHD-104: Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects with MDS or AML (clinicaltrials.gov)
    P1, N=160, Active, not recruiting, Shattuck Labs, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Nov 2024 | Trial primary completion date: Apr 2025 --> Nov 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • SL-172154
    1m
    Recombinant Humanized Anti-CD47/PD-1 Bifunctional Antibody HX009 in Patients With Relapsed/Refractory Lymphoma (clinicaltrials.gov)
    P1/2, N=99, Recruiting, Hangzhou Hanx Biopharmaceuticals, Ltd. | Trial completion date: Aug 2023 --> Dec 2026 | Trial primary completion date: Dec 2022 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    HX-009
    2ms
    A novel anti-CD47 antibody with therapeutic potential for NK/T-cell lymphoma. (PubMed, Hum Vaccin Immunother)
    In addition, in vivo experiments showed that the anti-CD47 mAb AK117 significantly inhibited the growth of subcutaneous xenograft tumors in SCID mice compared to the control antibody IgG. Our results indicate that targeting CD47 monoclonal antibodies is a potential therapeutic strategy for NKTCL.
    Journal • IO biomarker
    |
    CD47 (CD47 Molecule)
    |
    CD47 expression
    |
    ligufalimab (AK117)
    2ms
    Lymphoma cell-driven IL-16 is expressed in activated B-cell-like diffuse large Bcell lymphomas and regulates the pro-tumor microenvironment. (PubMed, Haematologica)
    This study demonstrates that IL-16 exerts a novel role in coordinating the bidirectional interactions between tumor progression and the TME. IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL.
    Journal
    |
    CD20 (Membrane Spanning 4-Domains A1) • IL6 (Interleukin 6) • IL10 (Interleukin 10) • CASP3 (Caspase 3) • IL16 (Interleukin 16) • SIRPA (Signal Regulatory Protein Alpha)
    |
    IL6 expression
    |
    amulirafusp alfa (IMM0306)
    2ms
    A Study of NI-1801 in Patients with Mesothelin Expressing Solid Cancers (clinicaltrials.gov)
    P1, N=70, Recruiting, Light Chain Bioscience - Novimmune SA | N=40 --> 70 | Trial completion date: Sep 2025 --> Sep 2026 | Trial primary completion date: Jun 2025 --> May 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    MSLN (Mesothelin)
    |
    MSLN expression
    |
    Keytruda (pembrolizumab) • paclitaxel • NI-1801
    2ms
    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
    2ms
    A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=80, Active, not recruiting, University of Colorado, Denver | Trial primary completion date: Sep 2024 --> Dec 2024
    Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • evorpacept (ALX148)
    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, 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)
    2ms
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Not yet recruiting, Akeso
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    2ms
    TTI-622 in Combination with Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=41, Recruiting, Mayo Clinic | N=62 --> 41
    Enrollment change • Combination therapy
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • IRF4 (Interferon regulatory factor 4)
    |
    ALK positive • BCL6 rearrangement • BCL2 rearrangement
    |
    Keytruda (pembrolizumab) • maplirpacept (TTI-622) • ontorpacept (PF-07901800)
    2ms
    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)
    2ms
    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)
    2ms
    A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=9, Completed, Celgene | Active, not recruiting --> Completed | N=100 --> 9 | Trial completion date: Aug 2025 --> Jul 2024 | Trial primary completion date: Aug 2025 --> Jul 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    2ms
    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) • NKTR-255
    2ms
    Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
    New P1 trial • Combination therapy • Metastases
    |
    Ameile (aumolertinib)
    2ms
    Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov)
    P1/2, N=4, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=70 --> 4 | Trial completion date: Feb 2029 --> May 2025 | Trial primary completion date: Feb 2027 --> May 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    lenalidomide • Monjuvi (tafasitamab-cxix) • maplirpacept (TTI-622)
    2ms
    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)
    2ms
    TTI-622-01: A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma (clinicaltrials.gov)
    P1, N=189, Terminated, Pfizer | Active, not recruiting --> Terminated; A business decision was made by Pfizer to terminate the study. Termination was not due to any safety concerns, requests from regulatory authorities, changes to the benefit/risk profile or any new concerns regarding the investigational product.
    Trial termination • Combination therapy • Metastases
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation • TP53 wild-type
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • azacitidine • carfilzomib • Sarclisa (isatuximab-irfc) • dexamethasone injection • maplirpacept (TTI-622)