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

Gastrointestinal Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04171141
• Other study ID #: C3861001
• Secondary ID: GUCY2C
• Status: Terminated
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Adenocarcinomas
• Digestive System Neoplasms
• Esophageal Adenocarcinomas
• Gastric Adenocarcinomas
• Gastrointestinal Neoplasms
• Gastrointestinal Tumors

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)

External Links

•   To obtain contact information for a study center near you, click here.