Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS

Patrocinadores

Patrocinador principal: Pfizer

Fuente Pfizer
Resumen breve

A phase 1, open‑label, dose escalation and expansion study of PF‑07062119 in patients with selected advanced or metastatic gastrointestinal tumors

Descripción detallada

This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-PD-1) and in combination with an anti-vascular endothelial growth factor (anti-VEGF). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-PD-1 and in combination with anti-VEGF (Part 1B) followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD 1 and in combination with anti-VEGF (Part 2).

Estado general Recruiting
Fecha de inicio November 19, 2019
Fecha de Terminación June 14, 2023
Fecha de finalización primaria June 14, 2023
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of participants with Dose-limiting toxicities (DLT) in Cycle 1 Baseline up to 28 days
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities Baseline up to approximately 24 months
Duration of Adverse Events (AEs) Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Severity Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Seriousness Baseline up to up to approximately 24 months
Number of Participants With Adverse Events (AEs) by Relationship Baseline up to approximately 24 months
Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2) Baseline (1st dosing) up to approximately 24 months
Resultado secundario
Medida Periodo de tiempo
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119 Up to approximately 24 months
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1 Up to approximately 24 months
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF Up to approximately 24 months
Apparent Clearance (CL/F) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Maximum Observed Plasma Concentration (Cmax) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Time to Reach Maximum Observed Plasma Concentration (Tmax) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Terminal Half-Life (t1/2) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Objective Response - Number of Participants With Objective Response for Dose Escalation Baseline up to 24 months
Objective Response - Number of Participants With Objective Response for Dose Finding portion Baseline up to 24 months
Minimum Observed Plasma Trough Concentration (Cmin) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Progression-Free Survival (PFS) for Dose Expansion Baseline to measured progressive disease (up to 24 months)
Duration of Response (DR) for Dose Expansion Baseline up to approximately 24 months
Change from baseline of immune cells from tumor biopsies Baseline and Cycle 2, Day 1 (each cycle is 28 days)
Inscripción 110
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: PF-07062119

Descripción: PF-07062119

Tipo de intervención: Drug

Nombre de intervención: Anti-PD1

Descripción: Anti-PD1 PF-06801591

Tipo de intervención: Drug

Nombre de intervención: Anti-VEGF

Descripción: Anti-VEGF IV (bevacizumab)

Elegibilidad

Criterios:

Inclusion Criteria:

- For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.

- For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1

- Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)

- Measurable disease as defined by RECIST 1.1 is required (Part 2)

Exclusion Criteria:

- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases

- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ

- Major surgery or radiation within 3 weeks prior to study entry

- Last anti-cancer treatment within 4 weeks prior to study entry

- Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication

- Active or history of clinically significant gastrointestinal disease

- Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry

- Pregnant or breastfeeding female patients

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Pfizer CT.gov Call Center Study Director Pfizer
Contacto general

Apellido: Pfizer CT.gov Call Center

Teléfono: 1-800-718-1021

Email: [email protected]

Ubicación
Instalaciones: Estado:
City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte, California, 91010, United States Recruiting
City of Hope IDS Pharmacy | Duarte, California, 91010, United States Recruiting
Anschutz Cancer Pavilion | Aurora, Colorado, 80045, United States Not yet recruiting
University of Colorado Denver CTO (CTRC) | Aurora, Colorado, 80045, United States Not yet recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) | Aurora, Colorado, 80045, United States Not yet recruiting
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) | Aurora, Colorado, 80045, United States Not yet recruiting
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora, Colorado, 80045, United States Not yet recruiting
University of Texas MD Anderson Cancer Center | Houston, Texas, 77030, United States Recruiting
Christus Santa Rosa Hospital | San Antonio, Texas, 78229, United States Recruiting
NEXT Oncology | San Antonio, Texas, 78229, United States Recruiting
National Cancer Center Hospital East | Kashiwa, Chiba, 277-8577, Japan Recruiting
Ubicacion Paises

Japan

United States

Fecha de verificación

June 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 7
Grupo de brazo

Etiqueta: Dose Escalation

Tipo: Experimental

Descripción: Single Agent Dose Escalation

Etiqueta: Dose Finding Anti-PD-1 Combination

Tipo: Experimental

Descripción: Part 1B PF-07062119 plus anti-PD-1

Etiqueta: Dose Finding anti-VEGF Combination

Tipo: Experimental

Descripción: Part 1B PF-07062119 plus anti-VEGF

Etiqueta: Dose Expansion Arm A

Tipo: Experimental

Descripción: PF-07062119 as a Single Agent in CRC

Etiqueta: Dose Expansion Arm B

Tipo: Experimental

Descripción: PF-07062119 in Combination with anti-PD-1 in CRC

Etiqueta: Dose Expansion Arm C

Tipo: Experimental

Descripción: PF-07062119 in Combination with anti-VEGF in CRC

Etiqueta: Dose Expansion Arm D

Tipo: Experimental

Descripción: PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types

Datos del paciente No
Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov