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    DRUG:

    JNJ-95298177

    i
    Other names: JNJ-95298177, JNJ-8177, ARX517, ARX517-PSMA-ADC, ARX 517, ARX-517, JNJ8177, JNJ 8177, JNJ95298177, JNJ 95298177
    Company:
    J&J
    Drug class:
    Tubulin inhibitor, PSMA-targeted antibody-drug conjugate
    Related drugs:
    23d
    APEX-01: ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1, N=352, Recruiting, Ambrx, Inc. | N=262 --> 352 | Trial completion date: Mar 2027 --> Dec 2028 | Trial primary completion date: Dec 2025 --> May 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    abiraterone acetate • prednisone • Erleada (apalutamide) • JNJ-95298177
    8ms
    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-95298177
    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.
    Trial completion date • Trial primary completion date • Metastases
    |
    FOLH1 (Folate hydrolase 1)
    |
    FOLH1 expression
    |
    Xtandi (enzalutamide) • JNJ-95298177
    1year
    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) • JNJ-95298177
    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-95298177
    almost2years
    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) • JNJ-95298177