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Um estudo para aprender sobre o Vepdegestrant quando administrado com PF-07220060 a pessoas com câncer de mama avançado ou metastático.

3 de setembro de 2026 atualizado por: Pfizer

UMA SEGURANÇA E EFICÁCIA INTERVENCIONAL FASE 1B/2, ESTUDO ABERTO PARA INVESTIGAR A TOLERABILIDADE, PK E ATIVIDADE ANTITUMORAL DO VEPDEGESTRANT (ARV-471/PF-07850327), UMA QUIMERA DIRECIONADA À PROTEÓLISE ORAL, EM COMBINAÇÃO COM PF-07220060 EM PARTICIPANTES DE IDADE 18 ANOS E MAIS COM CÂNCER DE MAMA AVANÇADO OU METASTÁTICO ER+/HER2-

The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that:

  • is hard to treat (advanced) and may have spread to other organs (metastatic).
  • is sensitive to hormonal therapy (it is called estrogen receptor positive).
  • is no longer responding to treatments taken before starting this study.

All the participants will receive vepdegestrant and PF-07220060. Both medicines will be taken by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicines are safe and effective. Participants will continue to take vepdegestrant and PF-07220060 until:

  • their cancer is no longer responding, or
  • side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

C4891026 is a prospective, open-label, multicenter, Phase 1b/2 study to evaluate the safety, antitumor activity, and pharmacokinetic (PK) of vepdegestrant in combination with PF-07220060 in the treatment of participants with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Advanced or Metastatic Breast Cancer.

Tipo de estudo

Intervencional

Inscrição (Real)

71

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Bélgica
    • Antwerpen
      • Edegem, Antwerpen, Bélgica, 2650
        • Antwerp University Hospital
    • Bruxelles-capitale, Région de
      • Anderlecht, Bruxelles-capitale, Région de, Bélgica, 1070
        • Institut Jules Bordet
    • Vlaams-brabant
      • Leuven, Vlaams-brabant, Bélgica, 3000
        • UZ Leuven
    • West-vlaanderen
      • Kortrijk, West-vlaanderen, Bélgica, 8500
        • AZ Groeninge Campus Kennedylaan
  • Canadá
    • Ontario
      • Ottawa, Ontario, Canadá, K1H 8L6
        • The Ottawa Hospital - General Campus
      • Toronto, Ontario, Canadá, M5G 2M9
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canadá, M4N 3M5
        • Sunnybrook Research Institute
  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
    • Hubei
      • Wuhan, Hubei, China, 430023
        • Wuhan Union Hospital Cancer Center
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
  • Espanha
      • Seville, Espanha, 41013
        • Hospital Universitario Virgen Del Rocio
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Espanha, 08035
        • Hospital Universitari Vall d'Hebron
    • Lleida [lérida]
      • Lleida, Lleida [lérida], Espanha, 25198
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Espanha, 28041
        • Hospital Universitario 12 de Octubre
  • Estados Unidos
    • Arkansas
      • Fayetteville, Arkansas, Estados Unidos, 72703
        • Highlands Oncology
      • Rogers, Arkansas, Estados Unidos, 72758
        • Highlands Oncology
      • Springdale, Arkansas, Estados Unidos, 72762
        • Highlands Oncology Group
    • California
      • Irvine, California, Estados Unidos, 92618
        • Hoag Hospital Irvine
      • Irvine, California, Estados Unidos, 92618
        • Hoag Health Center Irvine
      • Newport Beach, California, Estados Unidos, 92663
        • Hoag Memorial Hospital Presbyterian
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Cancer Center
      • Palo Alto, California, Estados Unidos, 94304
        • Clinical and Translational Research Unit (CTRU)
      • Palo Alto, California, Estados Unidos, 94304
        • Stanford Cancer Institute - Clinical Trials Office
      • San Francisco, California, Estados Unidos, 94158
        • UCSF Medical Center at Mission Bay
    • Colorado
      • Fort Collins, Colorado, Estados Unidos, 80524
        • UCHealth Poudre Valley Hospital
      • Fort Collins, Colorado, Estados Unidos, 80528
        • UCHealth Harmony
      • Greeley, Colorado, Estados Unidos, 80634
        • UCHealth Greeley Hospital
      • Loveland, Colorado, Estados Unidos, 80538
        • UCHealth - Medical Center of the Rockies
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06511
        • Smilow Cancer Hospital Phase 1 Unit
      • New Haven, Connecticut, Estados Unidos, 06510
        • Smilow Cancer Hospital - Yale New Haven Health
      • New Haven, Connecticut, Estados Unidos, 06510
        • Yale - New Haven Hospital - Yale Cancer Center
      • Trumbull, Connecticut, Estados Unidos, 06611
        • Smilow Cancer Hospital - Trumbull
    • Michigan
      • Grand Rapids, Michigan, Estados Unidos, 49546
        • START Midwest
    • New Jersey
      • Basking Ridge, New Jersey, Estados Unidos, 07920
        • MSK Basking Ridge
      • Middletown, New Jersey, Estados Unidos, 07748
        • MSK Monmouth
      • Montvale, New Jersey, Estados Unidos, 07645
        • MSK Bergen
    • New York
      • Commack, New York, Estados Unidos, 11725
        • MSK Commack
      • Harrison, New York, Estados Unidos, 10604
        • MSK Westchester
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, Estados Unidos, 10022
        • Rockefeller Outpatient Pavilion (53rd Street)
      • New York, New York, Estados Unidos, 10065
        • Evelyn H. Lauder Breast and Imaging Center (BAIC).
      • Uniondale, New York, Estados Unidos, 11553
        • MSK Nassau
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • START San Antonio
    • Utah
      • Farmington, Utah, Estados Unidos, 84025
        • University of Utah, Farmington Health Center
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Estados Unidos, 84106
        • University of Utah, Sugar House Health Center
      • South Jordan, Utah, Estados Unidos, 84106
        • South Jordan Health Center - University of Utah
      • West Valley City, Utah, Estados Unidos, 84119
        • START Mountain Region
  • França
    • Hérault
      • Montpellier, Hérault, França, 34298
        • Institut Régional du Cancer Montpellier
    • Loire-atlantique
      • Saint-Herblain, Loire-atlantique, França, 44805
        • Institut de Cancérologie de l'Ouest
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, França, 13273
        • Institut Paoli-Calmettes
  • Japão
      • Tokyo, Japão, 142-8666
        • Showa Medical University Hospital
    • Chiba
      • Kashiwa, Chiba, Japão, 277-8577
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japão, 2418515
        • Kanagawa cancer center
    • Tokyo
      • Chuo-ku, Tokyo, Japão, 104-0045
        • National Cancer Center Hospital
  • Porto Rico
      • Mayagüez, Porto Rico, 00680
        • BRCR Global - Mayaguez Administrative Office
      • Mayagüez, Porto Rico, 00682
        • BRCR Global - Mayagüez
      • Rio Piedras, Porto Rico, 00935
        • Pan American Center for Oncology Trials, LLC

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Histological or cytological diagnosis of breast cancer. At time of enrollment this must not be amenable to surgical resection with curative intent (≥1% ER+ stained cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or in-situ hybridization per ASCO/CAP).

  • prior anticancer therapies: Phase 1b: at least 1 line of SOC for A/MBC; Prior fulvestrant allowed; ≤1 prior chemotherapy line (no antibody-drug conjugates permitted) for A/MBC setting allowed. Phase 2: At least one and maximum 2 lines of ET in A/MBC setting and most recent ET-based regimen for >6 months.

    1, and only 1, prior CDK4/6 inhibitor-based regimen required. Up to 1 prior regimen of cytotoxic chemotherapy (no antibody-drug conjugates permitted) in the A/MBC setting; Prior fulvestrant allowed.

  • Participant with only non-measurable lesion (Phase1b) or at least 1 measurable lesion as defined by RECIST v1.1. (Phase2) are eligible.

  • ECOG PS = 0 or 1 (Phase1b) ; ≤2 (Phase2)

Exclusion Criteria:

  • visceral crisis at risk of life-threatening complications in the short term.
  • Any condition precluding an adeguate absorption of study interventions.
  • newly diagnosed brain metastases, or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 28 days prior to enrollment in the of study.
  • history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. Inflammatory breast cancer are excluded
  • impaired cardiovascular function or clinically significant cardiovascular diseases.
  • concurrent administration of medications, food, or herb supplements that are strong inhibitors/inducers of CYP3A or UGT2B7, moderate inducers of CYP34 (Phase1b only) and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
  • renal impairment, not adequate liver function and/or bone marrow function.
  • known active infection

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: vepdegestrant in combination with PF-07220060

vepdegestrant administered orally once daily (QD) continuously and PF-07220060 administered orally twice daily (BID) continuously on 28-day cycles
Medicamento: vepdegestrant

Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

Outros nomes:
  • ARV-471/PF07850327
Medicamento: PF-07220060

Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Dose-Limiting Toxicities (DLTs): Phase 1b
Prazo: Cycle 1 (28 days)

Hematological DLT: neutropenic fever; Grade>=3 thrombocytopenia associated with Grade>=2(clinically significant)bleeding and Grade4 neutropenia/thrombocytopenia lasting <7 days. Non-hematological: Grade>=3 toxicities clinically significant,except those that were not been maximally treated;Grade 2 aspartate aminotransferase(AST), alanine aminotransferase(ALT)/alkaline phosphatase(ALP) levels at baseline as result of liver/bone metastasis,AST,ALT and ALP level>8*baseline/AST/ALT >5*baseline for>=14 days; Hy's Law(concomitant ALT/AST elevation of >=3*upper limit of normal [ULN], total bilirubin elevation>=2*ULN without clear alternative etiology); Grade≥3 electrolyte abnormality with clinical sequelae; QTcF prolongation:any Grade>=3 QT prolongation without clear alternative etiology;any adverse event (AE) attributed to Vepdegestrant and/or PF-07220060 resulting in failure to deliver 75% of doses for either/both agents and any death not clearly due to underlying disease/extraneous causes.
Cycle 1 (28 days)
Percentage of Participants With Confirmed Objective Response (OR) by Derived Investigator Assessment: Phase 2
Prazo: From the date of first dose of study treatment combination until the first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum treatment exposure of 9.5 months for Phase 2)

OR was defined as best overall response (BOR) of confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1. CR was defined as complete disappearance of all target lesions, except for nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). PR was defined as at least a >=30% decrease from baseline in the sum of diameters of all target lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.
From the date of first dose of study treatment combination until the first documentation of disease progression (PD), death or start of new anticancer therapy, whichever occurred first (maximum treatment exposure of 9.5 months for Phase 2)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related TEAEs: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. Serious adverse event (SAE): any untoward medical occurrence, at any dose met one or more of following criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other important medical events. AEs includes both SAEs and all other AEs (non-SAEs). TEAEs will be those events with onset dates occurring during the on-treatment period. Relatedness to study drug judged by investigator.
From the date of first dose of study treatment combination through study completion
Number of Participants With Laboratory Abnormalities: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

Laboratory parameters assessed: hemoglobin, platelets, white blood cells (WBC), absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), sodium, potassium, magnesium, chloride, total calcium, total bilirubin, urea or blood urea nitrogen (BUN), creatinine, estimated glomerular filtration rate (eGFR), uric acid, glucose (fasted), albumin, phosphorus, lipase and amylase.
From the date of first dose of study treatment combination through study completion
Number of Participants With Electrocardiogram (ECG) Abnormalities: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes.
From the date of first dose of study treatment combination through study completion
Percentage of Participants With Confirmed OR by Derived Investigator Assessment: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

OR was defined as BOR of confirmed CR or PR according to RECIST v 1.1. CR was defined as complete disappearance of all target lesions, except for nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). PR was defined as at least a >=30% decrease from baseline in the sum of diameters of all target lesions. The short diameter was used in the sum for nodal target lesions, while the longest diameter was used in the sum for non-nodal target lesions, all target lesions were assessed.
From the date of first dose of study treatment combination through study completion
Duration of Response (DOR) by Derived Investigator Assessment: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

DoR: for participants with OR: time from first documentation of CR/PR to first documentation of PD/death. CR: complete disappearance of all target lesions (L), except nodal disease, complete disappearance of all non-target L and no new L. Both target and non-target nodes, must decrease to normal. PR: >=30% decrease from baseline in sum of diameters of target L. Short diameter used in sum for nodal target L, longest diameter used in sum for non-nodal target L. PD: 20% increase in sum of diameter of target measurable L above smallest sum observed, minimum absolute increase of 5 mm for target L/unequivocal progression of pre-existing L for non-target L. DOR censored on date of last adequate disease assessment for participants who did not have DOR event, discontinued study treatment due to withdrawal of consent prior to event, started new anticancer therapy prior to event, had event after gap of >2 missing disease assessments, or lost to follow-up. Kaplan-Meier method will be used.
From the date of first dose of study treatment combination through study completion
Clinical Benefit Response (CBR) by Derived Investigator Assessment: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

CBR was defined as percentage of participants with BOR of confirmed CR or PR at any time, or stable disease (SD) >=24 weeks as per RECIST v1.1. CR: complete disappearance of all target lesions, except for nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes, both target and non-target, must decrease to normal (short axis<10 mm). PR: at least >=30% decrease from baseline in sum of diameters of all target lesions. Short diameter was used in sum for nodal target lesions, while longest diameter was used in sum for non-nodal target lesions, all target lesions were assessed. SD: did not qualify for CR, PR, PD. All target lesions were assessed. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, minimum absolute increase of 5mm for target lesions/unequivocal progression of pre-existing lesions for non-target lesion.
From the date of first dose of study treatment combination through study completion
Progression Free Survival (PFS) by Derived Investigator Assessment: Phase 1b
Prazo: From the date of first dose of study treatment combination through study completion

PFS was defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, minimum absolute increase of 5mm for target lesions/unequivocal progression of pre-existing lesions for non-target lesion. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method will be used.
From the date of first dose of study treatment combination through study completion
Plasma Concentration of Vepdegestrant (ARV-471) and Its Epimer ARV-473: Phase 1b
Prazo: Cycle 1, Day 8: Pre-dose; Cycle 1 Day 15: Pre-dose, 30 minutes, 1, 2, 4 ,6, 8 and 12 hours post-dose; Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hour post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose

Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.
Cycle 1, Day 8: Pre-dose; Cycle 1 Day 15: Pre-dose, 30 minutes, 1, 2, 4 ,6, 8 and 12 hours post-dose; Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hour post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose
Plasma Concentration of PF-07220060: Phase 1b
Prazo: Pre-dose (0 hour) of Day 8 of Cycle 1; pre-dose (0 hour), 0.5,1,2,4,6,8 and 12 hours post-dose of Day 15 of Cycle 1; Pre-dose (0 hour) and anytime between 4 to 8 hour post-dose of Day 1 and 15 of Cycle 2; Pre-dose (0 hour) of Day 1 of Cycle 3, 5 and 7
Pre-dose (0 hour) of Day 8 of Cycle 1; pre-dose (0 hour), 0.5,1,2,4,6,8 and 12 hours post-dose of Day 15 of Cycle 1; Pre-dose (0 hour) and anytime between 4 to 8 hour post-dose of Day 1 and 15 of Cycle 2; Pre-dose (0 hour) of Day 1 of Cycle 3, 5 and 7
Steady State Maximum Observed Plasma Concentration (Cmax,ss) of Vepdegestrant (ARV-471) and Its Epimer ARV-473: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Cmax,ss was the steady-state maximum concentration of ARV-471 after multiple doses and was directly observed from data. ARV-473 is an epimer of ARV-471.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Cmax,ss of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Steady State Time to Maximum Plasma Concentration (Tmax,ss) of Vepdegestrant (ARV-471) and Its Epimer ARV-473: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Tmax,ss was the steady-state time to maximum plasma concentration after multiple doses and was directly observed from data. ARV-473 is an epimer of ARV-471. ARV-473 is an epimer of ARV-471.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Tmax,ss of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Tmax,ss was the steady-state time to maximum plasma concentration after multiple doses and was directly observed from data.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Steady State Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast,ss) of Vepdegestrant (ARV-471) and Its Epimer ARV-473: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

AUClast,ss was defined as area under the plasma concentration time curve from time zero to the last measurable concentration as steady state. AUClast,ss was calculated using linear/log trapezoidal method.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
AUClast,ss of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

AUClast,ss was defined as area under the plasma concentration time curve from time zero to the last measurable concentration as steady state. AUClast,ss was calculated using linear/log trapezoidal method.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Apparent Total Clearance (CL/F) of Vepdegestrant (ARV-471): Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by AUCinf. AUCinf was calculated as AUClast + (Clast/kel), where, AUClast= area under the concentration-time curve from time 0 to time of last measurable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
CL/F of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose administered divided by AUCinf. AUCinf was calculated as AUClast + (Clast/kel), where, AUClast= area under the concentration-time curve from time 0 to time of last measurable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Apparent Volume of Distribution (Vz/F) of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

Vz/F was calculated as Dose/(AUCinf * kel). AUCinf was calculated as AUClast + (Clast/kel), where, AUClast= area under the concentration-time curve from time 0 to time of last measurable concentration, Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
Terminal Half-Life (t1/2) of PF-07220060: Phase 1b
Prazo: Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15

T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Predose (0 hours), 0.5, 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 15
DOR by Derived Investigator Assessment: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

DOR: for participants with OR: time from first documentation of CR/PR to first documentation of PD/death. CR: complete disappearance of all target lesions (L), except nodal disease, complete disappearance of all non-target L and no new L. Both target and non-target nodes, must decrease to normal. PR: >=30% decrease from baseline in sum of diameters of target L. Short diameter used in sum for nodal target L, longest diameter used in sum for non-nodal target L. PD: 20% increase in sum of diameter of target measurable L above smallest sum observed, minimum absolute increase of 5 mm for target L/unequivocal progression of pre-existing L for non-target L. DOR censored on date of last adequate disease assessment for participants who did not have DOR event, discontinued study treatment due to withdrawal of consent prior to event, started new anticancer therapy prior to event, had event after gap of >2 missing disease assessments, or lost to follow-up. Kaplan-Meier method will be used.
From the date of first dose of study treatment combination through study completion
Percentage of Participants With CBR by Derived Investigator Assessment: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

CBR was defined as percentage of participants with BOR of confirmed CR or PR at any time, or stable disease (SD) >=24 weeks as per RECIST v1.1. CR: complete disappearance of all target lesions, except for nodal disease, complete disappearance of all non-target lesions and no new lesions. All nodes, both target and non-target, must decrease to normal (short axis<10 mm). PR: at least >=30% decrease from baseline in sum of diameters of all target lesions. Short diameter was used in sum for nodal target lesions, while longest diameter was used in sum for non-nodal target lesions, all target lesions were assessed. SD: did not qualify for CR, PR, PD. All target lesions were assessed. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, minimum absolute increase of 5mm for target lesions/unequivocal progression of pre-existing lesions for non-target lesion.
From the date of first dose of study treatment combination through study completion
PFS by Derived Investigator Assessment: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

PFS was defined as the time from the date of first dose of study interventions to the date of first documentation of PD or death due to any cause, whichever occurred first as per RECIST v1.1. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, minimum absolute increase of 5mm for target lesions/unequivocal progression of pre-existing lesions for non-target lesion. PFS was censored on the date of last adequate disease assessment for those who did not have a PFS event, discontinued the study treatment due to withdrawal of consent prior to an event, started a new anticancer therapy prior to an event, had an event after a gap of 2 or more missing disease assessments, or lost to follow-up. Kaplan-Meier method will be used.
From the date of first dose of study treatment combination through study completion
Overall Survival (OS): Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

OS was defined as the time from the date of first dose of study treatment combination to the date of death due to any cause. Participants last known to be alive were censored at the date of last contact. Kaplan-Meier method will be used.
From the date of first dose of study treatment combination through study completion
Number of Participants With TEAEs, TESAEs and Treatment Related TEAEs: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study treatment, whether or not considered related to study treatment. SAE: any untoward medical occurrence, at any dose met one or more of following criteria: death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or other important medical events. AEs includes both SAEs and all other AEs (non-SAEs). TEAEs will be those events with onset dates occurring during the on-treatment period. Relatedness to study drug judged by investigator.
From the date of first dose of study treatment combination through study completion
Number of Participants With ECG Abnormalities: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes.
From the date of first dose of study treatment combination through study completion
Number of Participants With Laboratory Abnormalities: Phase 2
Prazo: From the date of first dose of study treatment combination through study completion

Laboratory parameters assessed included hemoglobin, platelets, WBC, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, ALT, AST, ALP, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, urea or BUN, creatinine, eGFR, uric acid, glucose (fasted), albumin, phosphorus, lipase and amylase.
From the date of first dose of study treatment combination through study completion
Plasma Concentration of Vepdegestrant (ARV-471) and Its Epimer ARV-473: Phase 2
Prazo: Cycle 1, Day 15 and Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hour post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose

Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.
Cycle 1, Day 15 and Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hour post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose
Plasma Concentration of PF-07220060: Phase 2
Prazo: Cycle 1, Day 15 and Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hours post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose

Plasma concentrations of ARV-471 and its epimer ARV-473 were reported in this outcome measure.
Cycle 1, Day 15 and Cycle 2 Days 1 and 15: Pre-dose, anytime between 4 to 8 hours post-dose; Cycles 3, 5, and 7, Day 1: Pre-dose
Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Plasma Level: Phase 2
Prazo: Baseline and up to End of Treatment
Baseline and up to End of Treatment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

Colaboradores

Arvinas Estrogen Receptor, Inc.

Investigadores

  • Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

19 de fevereiro de 2024

Conclusão Primária (Real)

5 de setembro de 2025

Conclusão do estudo (Estimado)

25 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de dezembro de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de janeiro de 2024

Primeira postagem (Real)

16 de janeiro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • C4891026
  • 2023-508130-33-00 (Identificador de registro: CTIS (EU))
  • TACTIVE-K (Outro identificador: Alias Study Number)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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