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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04171141
Other study ID # C3861001
Secondary ID GUCY2C
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 19, 2019
Est. completion date November 28, 2023

Study information

Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Terminated
Enrollment 79
Est. completion date November 28, 2023
Est. primary completion date November 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
PF-07062119
PF-07062119
Anti-PD1
Anti-PD1 PF-06801591
Anti-VEGF
Anti-VEGF IV (bevacizumab)

Locations

Country Name City State
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia The Royal Melbourne Hospital Parkville Victoria
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Cancer Center Hospital East Kashiwa Chiba
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 University Hospitals Cleveland Medical Center Cleveland Ohio
United States 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 START Midwest Grand Rapids Michigan
United States University of Texas MD Anderson Cancer Center Houston Texas
United States UCLA Department of Medicine: Hematology-Oncology Los Angeles California
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 Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion New York New York
United States Christus Santa Rosa Hospital San Antonio Texas
United States NEXT Oncology San Antonio Texas
United States UCLA Hematology Oncology - Santa Monica Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with Dose-limiting toxicities (DLT) in Cycle 1 Baseline up to 28 days (or 42 days as applicable)
Primary Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities Baseline up to approximately 24 months
Primary Duration of Adverse Events (AEs) Baseline up to approximately 24 months
Primary Number of Participants With Adverse Events (AEs) According to Severity Baseline up to approximately 24 months
Primary Number of Participants With Adverse Events (AEs) According to Seriousness Baseline up to up to approximately 24 months
Primary Number of Participants With Adverse Events (AEs) by Relationship Baseline up to approximately 24 months
Primary Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2) Baseline (1st dosing) up to approximately 24 months
Secondary Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119 Up to approximately 24 months
Secondary Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1 Up to approximately 24 months
Secondary Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF Up to approximately 24 months
Secondary Apparent Clearance (CL/F) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Maximum Observed Plasma Concentration (Cmax) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Terminal Half-Life (t1/2) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Objective Response - Number of Participants With Objective Response for Dose Escalation Baseline up to 24 months
Secondary Objective Response - Number of Participants With Objective Response for Dose Finding portion Baseline up to 24 months
Secondary Minimum Observed Plasma Trough Concentration (Cmin) Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Secondary Progression-Free Survival (PFS) for Dose Expansion Baseline to measured progressive disease (up to 24 months)
Secondary Duration of Response (DR) for Dose Expansion Baseline up to approximately 24 months
Secondary Change from baseline of immune cells from tumor biopsies Baseline and Cycle 2, Day 1 (each cycle is 28 days)
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