Esophageal Cancer Clinical Trial

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

Summary

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

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Full Description

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).

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT04171141

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 13 Locations for this study

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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
City of Hope IDS Pharmacy
Duarte California, 91010, United States
UCLA Department of Medicine: Hematology-Oncology
Los Angeles California, 90055, United States
UCLA Hematology Oncology - Santa Monica
Santa Monica California, 90404, United States
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora Colorado, 80045, United States
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
New York New York, 10022, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York New York, 10065, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Christus Santa Rosa Hospital
San Antonio Texas, 78229, United States
NEXT Oncology
San Antonio Texas, 78229, United States
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
The Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Cancer Center Hospital
Chuo-ku Tokyo, 104-0, Japan

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT04171141

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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