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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:
    22d
    Neoadjuvant Immunoradiotherapy With Evorpacept and Pembrolizumab in HPVOPC (Human Papilloma Virus Oropharynx Cancer) (clinicaltrials.gov)
    P2, N=29, Active, not recruiting, University of California, San Diego | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Keytruda (pembrolizumab) • evorpacept (ALX148)
    1m
    ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, ALX Oncology Inc.
    Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • eribulin mesylate • vinorelbine tartrate • evorpacept (ALX148)
    2ms
    ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer (clinicaltrials.gov)
    P2, N=120, Recruiting, ALX Oncology Inc. | Phase classification: P1/2 --> P2 | N=80 --> 120 | Trial completion date: Dec 2027 --> Dec 2028 | Trial primary completion date: Jun 2027 --> Dec 2027
    Phase classification • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herceptin (trastuzumab) • gemcitabine • paclitaxel • capecitabine • eribulin mesylate • vinorelbine tartrate • evorpacept (ALX148)
    3ms
    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)
    3ms
    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)
    3ms
    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 • eribulin mesylate • vinorelbine tartrate • evorpacept (ALX148)
    4ms
    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 • eribulin mesylate • vinorelbine tartrate • evorpacept (ALX148)
    7ms
    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)
    8ms
    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)
    8ms
    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)
    9ms
    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 • eribulin mesylate • vinorelbine tartrate • evorpacept (ALX148)
    10ms
    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)