Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Reason given: Study was terminated due to strategic considerations and not due to safety.
Key facts
- Where
- Aurora, Cleveland, Duarte, Grand Rapids, Houston, Los Angeles, New York, San Antonio, and Santa Monica, United StatesSee the 15 sites
- Phase
- Phase 1
Where in United States
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Aurora, United StatesNo longer taking part
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Aurora, United StatesNo longer taking part
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Aurora, United StatesNo longer taking part
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNo longer taking part
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Duarte, United StatesNo longer taking part
- City of Hope IDS PharmacyDuarte, United StatesNo longer taking part
- START | MidwestGrand Rapids, United StatesNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesNo longer taking part
- Evelyn H. Lauder Breast and Imaging CenterNew York, United StatesNo longer taking part
- Memorial Sloan Kettering Cancer Center - Main CampusNew York, United StatesNo longer taking part
- Memorial Sloan Kettering Cancer Center Rockefeller Outpatient PavillionNew York, United StatesNo longer taking part
- Christus Santa Rosa HospitalSan Antonio, United StatesNo longer taking part
- NEXT OncologySan Antonio, United StatesNo longer taking part
- UCLA Hematology-Oncology - Santa MonicaSanta Monica, United StatesNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04171141
- Record updated
- 16 January 2025
- Original description
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumorsRead full original descriptionShow less
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
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
Inclusion: 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: 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; Participation in other studies involving investigational drug(s) within 2 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; Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases; Pregnant or breastfeeding female patients.