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    DRUG:

    evorpacept (ALX148)

    i
    Other names: ALX148, ALX 148, ALX-148, LGGL-ALX-148
    Company:
    ALX Oncology
    Drug class:
    CD47 inhibitor
    Related drugs:
    14d
    Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients With Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies. (PubMed, Clin Cancer Res)
    Although the sample size is small, these findings support the clinical benefit of zanidatamab treatment for HER2-positive SGC.
    Journal • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 positive + HER-2 overexpression
    |
    Ziihera (zanidatamab-hrii) • evorpacept (ALX148)
    18d
    ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=47, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Mar 2026 --> Mar 2028 | Trial completion date: Mar 2026 --> Mar 2028
    Trial completion date • Trial primary completion date
    |
    Rituxan (rituximab) • lenalidomide • Truxima (rituximab-abbs) • evorpacept (ALX148)
    20d
    ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies (clinicaltrials.gov)
    P1/2, N=80, Recruiting, ALX Oncology Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • CD47 (CD47 Molecule)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • evorpacept (ALX148)
    2ms
    AT148009: A Study of Evorpacept (ALX148) in Patients with Metastatic HER2-Positive Breast Cancer (2025-522012-16-00)
    P1/2, N=36, Not yet recruiting, Alx Oncology Holdings Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • evorpacept (ALX148)
    5ms
    Phase II clinical trial and preclinical evaluation of a novel CD47 blockade combination in refractory microsatellite stable metastatic colorectal cancer. (PubMed, Cancer Res Commun)
    Introduction In this preclinical human immune system patient-derived xenograft (HIS PDX) model and phase II clinical trial, we assessed evorpacept (anti-CD47 engineered fusion protein with inactive Fc), cetuximab, and pembrolizumab (triple therapy) in microsatellite stable colorectal cancer (MSS CRC). Conclusions While triple therapy demonstrated evidence of efficacy in refractory MSS CRC, safety concerns halted enrollment. Further investigation is necessary to determine the optimal use of CD47-targeted therapies in MSS CRC.
    P2 data • Preclinical • Journal
    |
    CD8 (cluster of differentiation 8)
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • evorpacept (ALX148)
    6ms
    HCB101: a novel potent ligand-trap Fc-fusion protein targeting the CD47-SIRPα pathway with high safety and preclinical efficacy for hematological and solid tumors. (PubMed, J Hematol Oncol)
    HCB101 demonstrates high-affinity binding to CD47, robustly promotes macrophage-mediated phagocytosis of tumor cells without affecting red blood cells and exhibits unique advantages over current CD47-targeting agents, including Hu5F9-G4, TTI-622, and ALX148. Additionally, HCB101 treatment increased the M1/M2 macrophage ratio in the tumor microenvironment, suggesting repolarization of tumor-associated macrophages (TAMs) toward a pro-inflammatory phenotype. No dose-limiting toxicities or hematologic adverse effects were observed in murine or non-human primate studies.
    Preclinical • Journal • IO biomarker
    |
    CD47 (CD47 Molecule) • SIRPA (Signal Regulatory Protein Alpha)
    |
    magrolimab (ONO-7913) • evorpacept (ALX148) • HCB101 • maplirpacept (TTI-622)
    6ms
    ZWI-ZW25-204: A Study of Zanidatamab (ZW25) With Evorpacept (ALX148) in Patients With Advanced HER2-expressing Cancer (clinicaltrials.gov)
    P1/2, N=52, Completed, Jazz Pharmaceuticals | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 positive + HER-2 overexpression
    |
    Ziihera (zanidatamab-hrii) • evorpacept (ALX148)
    7ms
    ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies (clinicaltrials.gov)
    P1/2, N=80, Recruiting, ALX Oncology Inc. | N=280 --> 80
    Enrollment change
    |
    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • evorpacept (ALX148)
    8ms
    A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) (clinicaltrials.gov)
    P2/3, N=127, Active, not recruiting, ALX Oncology Inc. | N=450 --> 127 | Trial completion date: Aug 2028 --> Jun 2026
    Enrollment change • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Herceptin (trastuzumab) • paclitaxel • Cyramza (ramucirumab) • evorpacept (ALX148)
    8ms
    Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) (clinicaltrials.gov)
    P2, N=172, Active, not recruiting, ALX Oncology Inc. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • 5-fluorouracil • evorpacept (ALX148)
    8ms
    A Study of Evorpacept (ALX148) in Patients With Advanced Solid Tumors and Lymphoma (ASPEN-01) (clinicaltrials.gov)
    P1, N=174, Completed, ALX Oncology Inc. | Trial completion date: Dec 2024 --> Jul 2025 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • cisplatin • paclitaxel • Rituxan (rituximab) • 5-fluorouracil • Cyramza (ramucirumab) • evorpacept (ALX148)
    8ms
    Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) (clinicaltrials.gov)
    P2, N=189, Active, not recruiting, ALX Oncology Inc. | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • evorpacept (ALX148)