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DRUG:

ebvaciclib (PF-06873600)

i
Other names: PF-06873600, PF 06873600, PF-3600
Company:
Pfizer
Drug class:
CDK2/4/6 inhibitor
8ms
First-In-Human Phase 1/2a Study of the First-In-Class CDK2/4/6 Inhibitor PF-06873600 Alone or with Endocrine Therapy in Patients with Breast Cancer. (PubMed, Clin Cancer Res)
PF-06873600 demonstrated a benefit-risk profile consistent with the CDK4/6 inhibitor class of drugs, with preliminary clinical activity in HR+/HER2- mBC.
P1/2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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fulvestrant • ebvaciclib (PF-06873600)
9ms
18F-FLT PET, a Non-Invasive Pharmacodynamic Biomarker of Tumor Cell Proliferation, Detected Differential Response to Various Cyclin Dependent Kinase (CDK) Inhibitors. (PubMed, Mol Cancer Ther)
Consistent with this observation, 18F-FLT PET was able to differentiate the resistance to Palbociclib from sensitivity to PF-06873600 (CDK2/4/6 inhibitor) and PF-07104091 in OVCAR-3 model. This work highlights the utility of 18F-FLT PET as a quantitative, non-invasive biomarker which provides whole-body information. 18F-FLT PET has potential to be a biomarker in novel CDK inhibitor clinical trials to evaluate Palbociclib resistance and identifying responding and non-responding patients.
PK/PD data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Ibrance (palbociclib) • ebvaciclib (PF-06873600) • tegtociclib (PF-07104091)
9ms
Individualized Pooled CRISPR/Cas9 Screenings Identify CDK2 as a Druggable Vulnerability in a Canine Mammary Carcinoma Patient. (PubMed, Vet Sci)
A comparison of essential genes for tumor cells survival identified CDK2 as a functional vulnerability in canine mammary tumors (CMTs) that can be targeted with the PF3600 inhibitor. Additional potential targets were also uncovered, providing insights for personalized cancer treatments in dogs.
Journal
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CDK2 (Cyclin-dependent kinase 2)
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ebvaciclib (PF-06873600)
10ms
C3661001: A Study of PF-06873600 in People With Cancer (clinicaltrials.gov)
P1/2, N=155, Terminated, Pfizer | Phase classification: P2 --> P1/2 | Active, not recruiting --> Terminated; Per business decision, but not due to safety concerns or regulatory request.
Phase classification • Trial termination
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative
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ebvaciclib (PF-06873600)
over2years
Discovery of targeted therapies for cancer patients: CDK2/4/6 inhibitor Ebvaciclib and EZH2 inhibitor PF-06821497 (ACS-Fall 2023)
Ebvaciclib, is a CDK2/4/6 inhibitor designed to be co-dosed with hormone therapy (letrozole or fulvestrant) to treat HR+ breast cancer. PF-06821497 is an EZH2 inhibitor currently being evaluated alone and in combination with enzalutamide to treat patients with castration resistant prostate cancer who have received either abiraterone and/or enzalutamide treatment and have evidence of prostate cancer progression. Discovery, synthesis, and early clinical results will be presented.
Clinical
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Xtandi (enzalutamide) • abiraterone acetate • fulvestrant • letrozole • ebvaciclib (PF-06873600) • mevrometostat (PF-06821497)
almost3years
C3661001: A Study of PF-06873600 in People With Cancer (clinicaltrials.gov)
P2, N=155, Active, not recruiting, Pfizer | Trial completion date: Apr 2023 --> Nov 2024
Trial completion date • Combination therapy
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HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
ebvaciclib (PF-06873600)
3years
C3661001: A Study of PF-06873600 in People With Cancer (clinicaltrials.gov)
P2, N=155, Active, not recruiting, Pfizer | Trial completion date: Jan 2024 --> Apr 2023
Trial completion date • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
ebvaciclib (PF-06873600)
3years
C3661001: A Study of PF-06873600 in People With Cancer (clinicaltrials.gov)
P2, N=155, Active, not recruiting, Pfizer | N=69 --> 155
Enrollment change • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
|
ebvaciclib (PF-06873600)
over3years
C3661001: A Study of PF-06873600 in People With Cancer (clinicaltrials.gov)
P2, N=69, Active, not recruiting, Pfizer | Recruiting --> Active, not recruiting | N=160 --> 69 | Trial completion date: Oct 2025 --> Jan 2024
Enrollment closed • Enrollment change • Trial completion date • Combination therapy
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HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
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ebvaciclib (PF-06873600)