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    DRUG:

    JNJ-8177

    i
    Other names: JNJ8177, JNJ 8177, JNJ-8177, ARX517, ARX517-PSMA-ADC, ARX 517, ARX-517
    Company:
    J&J
    Drug class:
    Tubulin inhibitor, PSMA-targeted antibody-drug conjugate
    Related drugs:
    6ms
    APEX-01: ARX517 in Subjects With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=262, Recruiting, Ambrx, Inc. | Phase classification: P1/2 --> P1
    Phase classification • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    JNJ-8177
    11ms
    APEX-01: ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=222, Recruiting, Ambrx, Inc.
    Trial completion date • Trial primary completion date • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Xtandi (enzalutamide capsule) • JNJ-8177
    12ms
    APEX-01: ARX517 as Monotherapy and in Combination Regimens in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=222, Recruiting, Ambrx, Inc. | N=150 --> 222
    Enrollment change • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Xtandi (enzalutamide capsule) • JNJ-8177
    over1year
    ARX517-2011: ARX517 in Subjects With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=150, Recruiting, Ambrx, Inc. | Phase classification: P1 --> P1/2 | N=76 --> 150 | Trial completion date: Aug 2024 --> Mar 2027 | Trial primary completion date: Feb 2024 --> Dec 2025
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    JNJ-8177
    over1year
    Preclinical characterization of ARX517, a next-generation anti-PSMA antibody drug conjugate for the treatment of metastatic castration-resistant prostate cancer (AACR 2023)
    The serum stability of ARX517 should effectively deliver more payload to target tumor cells, and in multiple CDX and PDX prostate cancer models, ARX517 showed dose-dependent anti-tumor activity in both enzalutamide-sensitive and enzalutamide-resistant models. The strong preclinical data and recent clinical validation of PSMA as a mCRPC target provide rationale for evaluation of ARX517 as a potential prostate cancer treatment. ARX517 is currently in a Phase 1 dose escalation trial (ARX517-2011 [NCT04662580]) in the United States.
    Preclinical • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression • FOLH1 overexpression
    |
    Xtandi (enzalutamide capsule) • JNJ-8177