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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:
3ms
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)
4ms
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)
1year
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)
over1year
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)
2years
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)
2years
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)
over2years
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)
3years
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)
over3years
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)
over3years
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)
over3years
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)
4years
Clinical
|
HER-2 (Human epidermal growth factor receptor 2)
|
praluzatamab ravtansine (CX-2009) • pacmilimab (CX-072)
4years
[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)