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

NCT ID: NCT04171141

Last Updated: 2025-01-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-19

Study Completion Date

2023-11-28

Brief Summary

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

Detailed Description

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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).

Conditions

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Gastrointestinal Tumors Colorectal Adenocarcinomas Gastric Adenocarcinomas Esophageal Adenocarcinomas

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

Single Agent Dose Escalation

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Dose Finding Anti-PD-1 Combination

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

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Anti-PD1

Intervention Type DRUG

Anti-PD1 PF-06801591

Dose Finding anti-VEGF Combination

Part 1B PF-07062119 plus anti-VEGF

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Anti-VEGF

Intervention Type DRUG

Anti-VEGF IV (bevacizumab)

Dose Expansion Arm A

PF-07062119 as a Single Agent in CRC

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Dose Expansion Arm B

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

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Dose Expansion Arm C

PF-07062119 in Combination with anti-VEGF in CRC

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Anti-PD1

Intervention Type DRUG

Anti-PD1 PF-06801591

Anti-VEGF

Intervention Type DRUG

Anti-VEGF IV (bevacizumab)

Dose Expansion Arm D

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

Group Type EXPERIMENTAL

PF-07062119

Intervention Type DRUG

PF-07062119

Anti-PD1

Intervention Type DRUG

Anti-PD1 PF-06801591

Anti-VEGF

Intervention Type DRUG

Anti-VEGF IV (bevacizumab)

Interventions

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PF-07062119

PF-07062119

Intervention Type DRUG

Anti-PD1

Anti-PD1 PF-06801591

Intervention Type DRUG

Anti-VEGF

Anti-VEGF IV (bevacizumab)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, United States

Site Status

City of Hope IDS Pharmacy

Duarte, California, United States

Site Status

UCLA Department of Medicine: Hematology-Oncology

Los Angeles, California, United States

Site Status

UCLA Hematology Oncology - Santa Monica

Santa Monica, California, United States

Site Status

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, United States

Site Status

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion

New York, New York, United States

Site Status

Evelyn H. Lauder Breast and Imaging Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Christus Santa Rosa Hospital

San Antonio, Texas, United States

Site Status

NEXT Oncology

San Antonio, Texas, United States

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Countries

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United States Australia Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3861001

To obtain contact information for a study center near you, click here.

Other Identifiers

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GUCY2C

Identifier Type: OTHER

Identifier Source: secondary_id

C3861001

Identifier Type: -

Identifier Source: org_study_id

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