- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171141
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
March 5, 2024 updated by: Pfizer
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3000
- Peter MacCallum Cancer Centre
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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-
-
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- National Cancer Center Hospital East
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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-
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California
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Duarte, California, United States, 91010
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
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Duarte, California, United States, 91010
- City of Hope IDS Pharmacy
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Los Angeles, California, United States, 90055
- UCLA Department of Medicine: Hematology-Oncology
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Santa Monica, California, United States, 90404
- UCLA Hematology Oncology - Santa Monica
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
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Michigan
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Grand Rapids, Michigan, United States, 49546
- Start Midwest
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center - Main Campus
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New York, New York, United States, 10022
- Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
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New York, New York, United States, 10065
- Evelyn H. Lauder Breast and Imaging Center
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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San Antonio, Texas, United States, 78229
- NEXT Oncology
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San Antonio, Texas, United States, 78229
- Christus Santa Rosa Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation
Single Agent Dose Escalation
|
PF-07062119
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Experimental: Dose Finding Anti-PD-1 Combination
Part 1B PF-07062119 plus anti-PD-1
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PF-07062119
Anti-PD1 PF-06801591
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Experimental: Dose Finding anti-VEGF Combination
Part 1B PF-07062119 plus anti-VEGF
|
PF-07062119
Anti-VEGF IV (bevacizumab)
|
Experimental: Dose Expansion Arm A
PF-07062119 as a Single Agent in CRC
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PF-07062119
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Experimental: Dose Expansion Arm B
PF-07062119 in Combination with anti-PD-1 in CRC
|
PF-07062119
|
Experimental: Dose Expansion Arm C
PF-07062119 in Combination with anti-VEGF in CRC
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PF-07062119
Anti-PD1 PF-06801591
Anti-VEGF IV (bevacizumab)
|
Experimental: Dose Expansion Arm D
PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
|
PF-07062119
Anti-PD1 PF-06801591
Anti-VEGF IV (bevacizumab)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with Dose-limiting toxicities (DLT) in Cycle 1
Time Frame: Baseline up to 28 days (or 42 days as applicable)
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Baseline up to 28 days (or 42 days as applicable)
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time Frame: Baseline up to approximately 24 months
|
Baseline up to approximately 24 months
|
Duration of Adverse Events (AEs)
Time Frame: Baseline up to approximately 24 months
|
Baseline up to approximately 24 months
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Number of Participants With Adverse Events (AEs) According to Severity
Time Frame: Baseline up to approximately 24 months
|
Baseline up to approximately 24 months
|
Number of Participants With Adverse Events (AEs) According to Seriousness
Time Frame: Baseline up to up to approximately 24 months
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Baseline up to up to approximately 24 months
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Number of Participants With Adverse Events (AEs) by Relationship
Time Frame: Baseline up to approximately 24 months
|
Baseline up to approximately 24 months
|
Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2)
Time Frame: Baseline (1st dosing) up to approximately 24 months
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Baseline (1st dosing) up to approximately 24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
|
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
Time Frame: Up to approximately 24 months
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Up to approximately 24 months
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Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1
Time Frame: Up to approximately 24 months
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Up to approximately 24 months
|
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF
Time Frame: Up to approximately 24 months
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Up to approximately 24 months
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Apparent Clearance (CL/F)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
|
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 - ∞)]
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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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)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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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)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
|
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
Time Frame: Baseline up to 24 months
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Baseline up to 24 months
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Objective Response - Number of Participants With Objective Response for Dose Finding portion
Time Frame: Baseline up to 24 months
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Baseline up to 24 months
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Minimum Observed Plasma Trough Concentration (Cmin)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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Progression-Free Survival (PFS) for Dose Expansion
Time Frame: Baseline to measured progressive disease (up to 24 months)
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Baseline to measured progressive disease (up to 24 months)
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Duration of Response (DR) for Dose Expansion
Time Frame: Baseline up to approximately 24 months
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Baseline up to approximately 24 months
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Change from baseline of immune cells from tumor biopsies
Time Frame: Baseline and Cycle 2, Day 1 (each cycle is 28 days)
|
Baseline and Cycle 2, Day 1 (each cycle is 28 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2019
Primary Completion (Actual)
November 28, 2023
Study Completion (Actual)
November 28, 2023
Study Registration Dates
First Submitted
November 8, 2019
First Submitted That Met QC Criteria
November 18, 2019
First Posted (Actual)
November 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C3861001
- GUCY2C (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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