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

Stopped early · Phase 1

Conditions studied: Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas

In brief

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

Key facts

Study ID

NCT04171141

Run by

Pfizer

People needed

79

Starts

2019-11-19

Expected to finish

2023-11-28

Last updated by the study team

2025-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• City of Hope IDS Pharmacy — Duarte, California, United States
• UCLA Department of Medicine: Hematology-Oncology — Los Angeles, California, United States
• UCLA Hematology Oncology - Santa Monica — Santa Monica, California, United States
• University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) — Aurora, Colorado, United States
• University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
• START Midwest — Grand Rapids, Michigan, United States
• Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion — New York, New York, United States
• Evelyn H. Lauder Breast and Imaging Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center - Main Campus — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Christus Santa Rosa Hospital — San Antonio, Texas, United States
• NEXT Oncology — San Antonio, Texas, United States
• Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
• The Royal Melbourne Hospital — Parkville, Victoria, Australia
• National Cancer Center Hospital East — Kashiwa, Chiba, Japan
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.