Back to resultsStudy to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Primary Purpose
Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
PF-07062119
Anti-PD1
Anti-VEGF
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Tumors focused on measuring Gastric cancer, Esophageal cancer, Colorectal cancer, Advanced esophageal cancer, Metastatic esophageal cancer, Advanced colorectal cancer, Metastatic gastric cancer, Advanced gastric cancer, Metastatic colorectal cancer, GUCY2c, Anti-PD1, Anti-VEGF, Measurable disease, PF-07062119, PF-06801591, Bevacizumab
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
Sites / Locations
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center)Recruiting
- City of Hope IDS PharmacyRecruiting
- UCLA Department of Medicine: Hematology-OncologyRecruiting
- UCLA Hematology Oncology - Santa MonicaRecruiting
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)Recruiting
- University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)Recruiting
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)Recruiting
- START Midwest
- Memorial Sloan Kettering Cancer Center Rockefeller Outpatient PavillionRecruiting
- Evelyn H. Lauder Breast and Imaging CenterRecruiting
- Memorial Sloan Kettering Cancer Center - Main CampusRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- University of Texas MD Anderson Cancer CenterRecruiting
- Christus Santa Rosa HospitalRecruiting
- NEXT OncologyRecruiting
- Peter MacCallum Cancer CentreRecruiting
- The Royal Melbourne HospitalRecruiting
- National Cancer Center Hospital EastRecruiting
- National Cancer Center HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose Escalation
Dose Finding Anti-PD-1 Combination
Dose Finding anti-VEGF Combination
Dose Expansion Arm A
Dose Expansion Arm B
Dose Expansion Arm C
Dose Expansion Arm D
Arm Description
Single Agent Dose Escalation
Part 1B PF-07062119 plus anti-PD-1
Part 1B PF-07062119 plus anti-VEGF
PF-07062119 as a Single Agent in CRC
PF-07062119 in Combination with anti-PD-1 in CRC
PF-07062119 in Combination with anti-VEGF in CRC
PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
Outcomes
Primary Outcome Measures
Number of participants with Dose-limiting toxicities (DLT) in Cycle 1
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Duration of Adverse Events (AEs)
Number of Participants With Adverse Events (AEs) According to Severity
Number of Participants With Adverse Events (AEs) According to Seriousness
Number of Participants With Adverse Events (AEs) by Relationship
Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2)
Secondary Outcome Measures
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF
Apparent Clearance (CL/F)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Terminal Half-Life (t1/2)
Objective Response - Number of Participants With Objective Response for Dose Escalation
Objective Response - Number of Participants With Objective Response for Dose Finding portion
Minimum Observed Plasma Trough Concentration (Cmin)
Progression-Free Survival (PFS) for Dose Expansion
Duration of Response (DR) for Dose Expansion
Change from baseline of immune cells from tumor biopsies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04171141
Brief Title
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
September 12, 2025 (Anticipated)
Study Completion Date
September 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
Keywords
Gastric cancer, Esophageal cancer, Colorectal cancer, Advanced esophageal cancer, Metastatic esophageal cancer, Advanced colorectal cancer, Metastatic gastric cancer, Advanced gastric cancer, Metastatic colorectal cancer, GUCY2c, Anti-PD1, Anti-VEGF, Measurable disease, PF-07062119, PF-06801591, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Single Agent Dose Escalation
Arm Title
Dose Finding Anti-PD-1 Combination
Arm Type
Experimental
Arm Description
Part 1B PF-07062119 plus anti-PD-1
Arm Title
Dose Finding anti-VEGF Combination
Arm Type
Experimental
Arm Description
Part 1B PF-07062119 plus anti-VEGF
Arm Title
Dose Expansion Arm A
Arm Type
Experimental
Arm Description
PF-07062119 as a Single Agent in CRC
Arm Title
Dose Expansion Arm B
Arm Type
Experimental
Arm Description
PF-07062119 in Combination with anti-PD-1 in CRC
Arm Title
Dose Expansion Arm C
Arm Type
Experimental
Arm Description
PF-07062119 in Combination with anti-VEGF in CRC
Arm Title
Dose Expansion Arm D
Arm Type
Experimental
Arm Description
PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
Intervention Type
Drug
Intervention Name(s)
PF-07062119
Intervention Description
PF-07062119
Intervention Type
Drug
Intervention Name(s)
Anti-PD1
Intervention Description
Anti-PD1 PF-06801591
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF
Intervention Description
Anti-VEGF IV (bevacizumab)
Primary Outcome Measure Information:
Title
Number of participants with Dose-limiting toxicities (DLT) in Cycle 1
Time Frame
Baseline up to 28 days (or 42 days as applicable)
Title
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Time Frame
Baseline up to approximately 24 months
Title
Duration of Adverse Events (AEs)
Time Frame
Baseline up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) According to Severity
Time Frame
Baseline up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) According to Seriousness
Time Frame
Baseline up to up to approximately 24 months
Title
Number of Participants With Adverse Events (AEs) by Relationship
Time Frame
Baseline up to approximately 24 months
Title
Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2)
Time Frame
Baseline (1st dosing) up to approximately 24 months
Secondary Outcome Measure Information:
Title
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
Title
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119
Time Frame
Up to approximately 24 months
Title
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1
Time Frame
Up to approximately 24 months
Title
Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF
Time Frame
Up to approximately 24 months
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Objective Response - Number of Participants With Objective Response for Dose Escalation
Time Frame
Baseline up to 24 months
Title
Objective Response - Number of Participants With Objective Response for Dose Finding portion
Time Frame
Baseline up to 24 months
Title
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
Title
Progression-Free Survival (PFS) for Dose Expansion
Time Frame
Baseline to measured progressive disease (up to 24 months)
Title
Duration of Response (DR) for Dose Expansion
Time Frame
Baseline up to approximately 24 months
Title
Change from baseline of immune cells from tumor biopsies
Time Frame
Baseline and Cycle 2, Day 1 (each cycle is 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope IDS Pharmacy
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Department of Medicine: Hematology-Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90055
Country
United States
Individual Site Status
Recruiting
Facility Name
UCLA Hematology Oncology - Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
START Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Name
Evelyn H. Lauder Breast and Imaging Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center - Main Campus
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Christus Santa Rosa Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3861001
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
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