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    DRUG:

    praluzatamab ravtansine (CX-2009)

    i
    Other names: CX-2009, CD166 PDC, CD166-targeting probody drug conjugate
    Company:
    AbbVie, CytomX
    Drug class:
    Microtubule inhibitor, CD166-targeted antibody-drug conjugate
    Related drugs:
    11ms
    CTMX-2009-002: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=125, Completed, CytomX Therapeutics | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    12ms
    PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors (clinicaltrials.gov)
    P1/2, N=99, Terminated, CytomX Therapeutics | Completed --> Terminated; Covid Pandemic; Business Decision to separate Phase 2 to new study
    Trial termination • Metastases
    |
    praluzatamab ravtansine (CX-2009)
    almost2years
    CTMX-2009-002: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=125, Active, not recruiting, CytomX Therapeutics | Trial completion date: Sep 2023 --> Apr 2023 | Trial primary completion date: Sep 2023 --> Apr 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    over2years
    CTMX-2009-002: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=125, Active, not recruiting, CytomX Therapeutics | Recruiting --> Active, not recruiting | N=200 --> 125
    Enrollment closed • Enrollment change • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    over2years
    CTMX-2009-002: Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=200, Recruiting, CytomX Therapeutics | N=150 --> 200 | Trial completion date: Mar 2023 --> Sep 2023 | Trial primary completion date: Mar 2023 --> Sep 2023
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    almost3years
    Praluzatamab ravtansine, a CD166-targeting antibody-drug conjugate, in patients with advanced solid tumors: an open-label phase 1/2 trial. (PubMed, Clin Cancer Res)
    CD166 is a novel, ubiquitously expressed target. CX-2009 is the first conditionally activated antibody-drug conjugate to CD166 to demonstrate both translational and clinical activity in a variety of tumor types.
    P1/2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive
    |
    praluzatamab ravtansine (CX-2009)
    3years
    Trial in progress: Phase 2, open-label study to evaluate the safety and efficacy of praluzatamab ravtansine in metastatic HER2 non-amplified breast cancer as monotherapy and combination with pacmilimab (SABCS 2021)
    This study will also evaluate safety and tolerability, pharmacokinetics, and antidrug antibodies with praluzatamab ravtansine as monotherapy and in combination with pacmilimab. This trial is enrolling (NCT04596150).
    Clinical • P2 data
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 amplification • PD-L1 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    almost4years
    [VIRTUAL] Phase II, open-label study to evaluate the safety and efficacy of praluzatamab ravtansine (CX 2009) in metastatic HR-positive/HER2 non-amplified breast cancer (mHR+/HER2− BC) and CX-2009 as monotherapy and in combination with pacmilimab in metastatic triple-negative breast cancer (mTNBC) (ESMO-BC 2021)
    This study will also evaluate safety and tolerability, pharmacokinetics, and antidrug antibodies with CX-2009 as monotherapy and in combination with pacmilimab. This trial is enrolling (NCT04596150).
    Clinical • P2 data • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • PD-L1 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    almost4years
    Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=150, Recruiting, CytomX Therapeutics | Not yet recruiting --> Recruiting
    Clinical • Enrollment open • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    4years
    Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=150, Not yet recruiting, CytomX Therapeutics
    Clinical • New P2 trial • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive • HR positive • HER-2 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    4years
    [VIRTUAL] A Phase 2, open-label study to evaluate the safety and efficacy of the probody therapeutic (Pb-Tx) CX‑2009 in metastatic HR-Positive/HER2-negative breast cancer (mHR+/HER2− BC) and of CX-2009 as monotherapy and in combination therapy with CX-072 in metastatic triple-negative breast cancer (TNBC) (SABCS 2020)
    This trial is actively enrolling. Email address for questions or comments: gpaton@cytomx.com
    Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive • HER-2 negative • HER-2 expression • PD-L1 negative • HR positive + HER-2 negative
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    over4years
    [VIRTUAL] CX-2009, a CD166-directed Probody drug conjugate, alone and combined with CX-072, anti–PD-L1 Probody therapeutic, in patients (Pts) with advanced cancer including HER2- negative breast cancer. (ASCO 2020)
    No abstract available
    Clinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
    over4years
    [VIRTUAL] CX-2009, a CD166-directed probody drug conjugate (PDC): Results from the first-in-human study in patients (Pts) with advanced cancer including breast cancer (BC). (ASCO 2020)
    CX-2009 at 7 mpk is the RP2D on Q3W schedule. Phase II expansion has begun in pts with HR+/HER2- BC. The Q2W schedule will continue to enroll pts to define the RP2D.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)