^
    6d
    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    P1, N=0, Withdrawn, National Cancer Institute (NCI) | N=33 --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 Withdrawn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 (GS-4721)
    7d
    MagnetisMM-20: A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=90, Recruiting, Pfizer | Trial primary completion date: Aug 2025 --> Feb 2026
    Trial primary completion date • Combination therapy
    |
    carfilzomib • Elrexfio (elranatamab-bcmm) • maplirpacept (TTI-622)
    8d
    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 (GS-4721) • Qarziba (dinutuximab beta) • Unituxin (dinutuximab)
    9d
    A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy
    |
    Venclexta (venetoclax) • azacitidine • ligufalimab (AK117)
    20d
    BAT7104 in Patients With Advanced Solid Tumours (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, Bio-Thera Solutions | Trial primary completion date: Jan 2024 --> Sep 2024
    Trial primary completion date • Metastases
    22d
    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 (GS-4721)
    23d
    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 (GS-4721)
    26d
    A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas (clinicaltrials.gov)
    P1, N=12, Completed, ImmuneOncia Therapeutics Inc. | Recruiting --> Completed | N=24 --> 12
    Trial completion • Enrollment change • Metastases
    |
    IMC002
    26d
    A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy (clinicaltrials.gov)
    P1, N=49, Recruiting, ImmuneOncia Therapeutics Inc. | N=24 --> 49 | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jul 2024 --> Jun 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    IMC002
    30d
    Study of TG-1801 in Subjects With B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=50, Completed, TG Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    |
    Briumvi (ublituximab-xiiy) • TG-1801
    1m
    Study of Maplirpacept (PF-07901801) in Combination With PLD in Patients With Platinum-Resistant Ovarian Cancer (clinicaltrials.gov)
    P1/2, N=10, Terminated, Pfizer | Active, not recruiting --> Terminated; A business decision was made by Pfizer to terminate and remove the Phase 2 expansion of this study for administrative reasons. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
    Trial termination • Combination therapy
    |
    pegylated liposomal doxorubicin • maplirpacept (TTI-622)
    1m
    A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma. (clinicaltrials.gov)
    P1/2, N=70, Recruiting, Pfizer | Phase classification: P2 --> P1/2
    Phase classification • Combination therapy
    |
    Gazyva (obinutuzumab) • Columvi (glofitamab-gxbm) • maplirpacept (TTI-622)
    1m
    KEVLARx: RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer (clinicaltrials.gov)
    P2, N=216, Recruiting, EpicentRx, Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    cisplatin • nibrozetone (RRx-001)
    1m
    Study to Test the Safety and Tolerability of PF-07257876 in Participants With Selected Advanced Tumors. (clinicaltrials.gov)
    P1, N=29, Completed, Pfizer | Active, not recruiting --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    PF-07257876
    1m
    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 (GS-4721)
    1m
    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, Recruiting, EpicentRx, Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • etoposide IV • nibrozetone (RRx-001)
    1m
    REPLATINUM: RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=18, Terminated, EpicentRx, Inc. | Trial completion date: Aug 2022 --> Mar 2024
    Trial completion date
    |
    cisplatin • carboplatin • etoposide IV • nibrozetone (RRx-001)
    1m
    03-OHD-104: Phase 1 Study of Shattuck Labs (SL)-172154 in Subjects With MDS or AML (clinicaltrials.gov)
    P1, N=160, Recruiting, Shattuck Labs, Inc. | N=107 --> 160 | Trial completion date: Oct 2024 --> Dec 2025 | Trial primary completion date: Feb 2024 --> Apr 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    TP53 (Tumor protein P53)
    |
    TP53 mutation
    |
    Venclexta (venetoclax) • azacitidine • SL-172154
    1m
    PIRATE: RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors (clinicaltrials.gov)
    P1, N=24, Active, not recruiting, EpicentRx, Inc. | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    temozolomide • irinotecan • nibrozetone (RRx-001)
    1m
    MagnetisMM-20: A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=90, Recruiting, Pfizer | N=14 --> 90
    Enrollment change • Combination therapy
    |
    carfilzomib • Elrexfio (elranatamab-bcmm) • maplirpacept (TTI-622)
    1m
    A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes (clinicaltrials.gov)
    P2, N=90, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    azacitidine • ligufalimab (AK117)
    2ms
    An "All-in-one" Immunomodulator-Engineered Clinical Translatable Immunotherapy of Advanced Hepatocellular Carcinoma. (PubMed, Adv Healthc Mater)
    The use of RRx-001 with the function of downregulating the expression of innate immune checkpoint molecule CD47 provides a powerful means for treating advanced HCC containing a substantial proportion of immunosuppressive macrophages...Combined with the ROS generation and an upregulated "eat me" signal level of DOX, BEA-D@R collectively increased RNS generation, enhanced T cell infiltration, and maximized macrophage phagocytosis, leading to an average of 40% tumor elimination in a mice model bearing an initial tumor of approximately 300 mm3 that mimics advanced HCC. Overall, this study uncovered the "all-in-one" immunotherapeutic functionalities of a clinical translatable nanoplatform for enhanced immunotherapy of advanced HCC.
    Journal • PD(L)-1 Biomarker • IO biomarker • Immunomodulating • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD47 (CD47 Molecule)
    |
    CD47 expression
    |
    nibrozetone (RRx-001)
    2ms
    A Study of Evorpacept (ALX148) With Enfortumab Vedotin for Subjects With Urothelial Carcinoma (ASPEN-07) (clinicaltrials.gov)
    P1, N=30, Recruiting, ALX Oncology Inc. | Trial primary completion date: Jan 2024 --> Dec 2024
    Trial primary completion date • Combination therapy
    |
    Padcev (enfortumab vedotin-ejfv) • evorpacept (ALX148)
    2ms
    A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01) (clinicaltrials.gov)
    P1, N=174, Active, not recruiting, ALX Oncology Inc. | Trial completion date: Feb 2024 --> Dec 2024
    Trial completion date • Metastases
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • paclitaxel • Rituxan (rituximab) • 5-fluorouracil • Cyramza (ramucirumab) • evorpacept (ALX148)
    2ms
    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 (GS-4721) • Onureg (azacitidine oral)
    2ms
    Effects of a humanized CD47 antibody and recombinant SIRPα proteins on triple negative breast carcinoma stem cells. (PubMed, Front Cell Dev Biol)
    This indicates that SIRPα-Fc has CD47-mediated agonist activities in breast cancer stem cells affecting proliferation and metastasis pathways that differ from those of CC-90002. This SIRPα-induced CD47 signaling in breast carcinoma cells may limit the efficacy of SIRPα decoy therapeutics intended to stimulate innate antitumor immune responses.
    Journal
    |
    CD47 (CD47 Molecule) • ALDH1A1 (Aldehyde Dehydrogenase 1 Family Member A1) • SIRPA (Signal Regulatory Protein Alpha)
    |
    CD47 expression
    |
    CC-90002
    2ms
    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 (GS-4721)
    2ms
    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 (GS-4721)
    2ms
    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 (GS-4721)
    2ms
    TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. (clinicaltrials.gov)
    P1, N=114, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial • Metastases
    |
    Anniko (penpulimab)
    2ms
    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 (GS-4721)
    2ms
    A Phase I Clinical Study of HMPL-A83 in Patients With Advanced Malignant Neoplasm (clinicaltrials.gov)
    P1, N=99, Recruiting, Hutchmed | Trial primary completion date: Feb 2024 --> Jun 2025
    Trial primary completion date • Metastases
    2ms
    KEVLARx: RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer (clinicaltrials.gov)
    P2, N=216, Not yet recruiting, EpicentRx, Inc. | Initiation date: Dec 2023 --> Apr 2024
    Trial initiation date • Metastases
    |
    cisplatin • nibrozetone (RRx-001)
    2ms
    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 (GS-4721)
    2ms
    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, Recruiting, Gilead Sciences | Trial primary completion date: Feb 2024 --> Mar 2025
    Trial primary completion date • Combination therapy • Metastases
    |
    RAS wild-type
    |
    Avastin (bevacizumab) • 5-fluorouracil • irinotecan • leucovorin calcium • magrolimab (GS-4721)
    2ms
    PT886 For Treatment of Patients With Metastatic/Advanced Gastric, Gastroesophageal Junction and Pancreatic Adenocarcinoma (the TWINPEAK Study) (clinicaltrials.gov)
    P1/2, N=114, Recruiting, Phanes Therapeutics | N=72 --> 114
    Enrollment change
    |
    CLDN18 (Claudin 18)
    |
    HER-2 overexpression • CLDN18.2 expression
    |
    Keytruda (pembrolizumab) • gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • PT886
    2ms
    Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer) (clinicaltrials.gov)
    P2, N=29, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2024 --> Aug 2026
    Enrollment open • Trial primary completion date • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • evorpacept (ALX148)
    2ms
    TTI-621-03: A Study to Learn About the Study Medicine (Called Ontorpacept or TTI-621) Given Alone and in Combination With Doxorubicin in People With Leiomyosarcoma (clinicaltrials.gov)
    P2, N=76, Terminated, Pfizer | Phase classification: P1/2 --> P2 | Active, not recruiting --> Terminated; Pfizer decided to terminate the study for administrative reasons. The termination was neither due to safety concerns nor a request from the regulatory authorities.
    Phase classification • Trial termination • Combination therapy • Metastases
    |
    doxorubicin hydrochloride • ontorpacept (PF-07901800)
    2ms
    A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
    P1/2, N=105, Completed, I-Mab Biopharma Co. Ltd. | Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    azacitidine • lemzoparlimab (ABBV-IMAB-TJC4)
    2ms
    SG2501 Safety Study in Subjects With Relapsed or Refractory Hematological Malignancies and Lymphoma. (clinicaltrials.gov)
    P1, N=72, Recruiting, Hangzhou Sumgen Biotech Co., Ltd. | Phase classification: P1a/1b --> P1
    Phase classification
    |
    SG2501
    2ms
    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 | Recruiting --> Active, not recruiting | N=13 --> 7
    Enrollment closed • Enrollment change
    |
    maplirpacept (TTI-622)
    3ms
    PNOC025: Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors (clinicaltrials.gov)
    P1, N=24, Suspended, University of California, San Francisco | Recruiting --> Suspended
    Trial suspension
    |
    magrolimab (GS-4721)