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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04171141




Registration number
NCT04171141
Ethics application status
Date submitted
8/11/2019
Date registered
20/11/2019

Titles & IDs
Public title
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Scientific 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
Secondary ID [1] 0 0
GUCY2C
Secondary ID [2] 0 0
C3861001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Tumors 0 0
Colorectal Adenocarcinomas 0 0
Gastric Adenocarcinomas 0 0
Esophageal Adenocarcinomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Oesophageal (gullet)
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-07062119
Treatment: Drugs - Anti-PD1
Treatment: Drugs - Anti-VEGF

Experimental: Dose Escalation - Single Agent Dose Escalation

Experimental: Dose Finding Anti-PD-1 Combination - Part 1B PF-07062119 plus anti-PD-1

Experimental: Dose Finding anti-VEGF Combination - Part 1B PF-07062119 plus anti-VEGF

Experimental: Dose Expansion Arm A - PF-07062119 as a Single Agent in CRC

Experimental: Dose Expansion Arm B - PF-07062119 in Combination with anti-PD-1 in CRC

Experimental: Dose Expansion Arm C - PF-07062119 in Combination with anti-VEGF in CRC

Experimental: Dose Expansion Arm D - PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types


Treatment: Drugs: PF-07062119
PF-07062119

Treatment: Drugs: Anti-PD1
Anti-PD1 PF-06801591

Treatment: Drugs: Anti-VEGF
Anti-VEGF IV (bevacizumab)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1
Timepoint [1] 0 0
28 Days
Primary outcome [2] 0 0
Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs
Timepoint [2] 0 0
4 Years
Primary outcome [3] 0 0
Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs
Timepoint [3] 0 0
4 Years
Primary outcome [4] 0 0
Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities
Timepoint [4] 0 0
4 Years
Primary outcome [5] 0 0
Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities
Timepoint [5] 0 0
4 Years
Secondary outcome [1] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts
Timepoint [1] 0 0
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Secondary outcome [2] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts
Timepoint [2] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1
Secondary outcome [3] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts
Timepoint [3] 0 0
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Secondary outcome [4] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts
Timepoint [4] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1
Secondary outcome [5] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts
Timepoint [5] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1
Secondary outcome [6] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUCtau - Non-Priming Cohorts
Timepoint [6] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1
Secondary outcome [7] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Day 1 to Day 7 (168 Hours) (AUC168) - Priming Cohorts
Timepoint [7] 0 0
Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1
Secondary outcome [8] 0 0
Cycle 1 and Cycle 4 PF-07062119 PK Parameters: AUC168 - Non-Priming Cohorts
Timepoint [8] 0 0
Cycle 1 Day 1 and Cycle 4 Day 1
Secondary outcome [9] 0 0
Pre-dose Trough Concentrations After Multiple Doses of PF-07062119
Timepoint [9] 0 0
Cycle 1 Day 15, Cycle 2 Days 1 and 15, Cycle 3 Days 1 and 15, Cycle 4 Days 1 and 15, Cycle 5 Day 1, Cycle 8 Day 1 and Cycle 11 Day 1
Secondary outcome [10] 0 0
Incidence of Anti-Drug Antibody (ADA) Positive Against PF-07062119
Timepoint [10] 0 0
Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Secondary outcome [11] 0 0
Titers of ADA Against PF-07062119
Timepoint [11] 0 0
Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and End of Treatment
Secondary outcome [12] 0 0
Incidence of Neutralizing Antibody (NAb) Positive Against PF-07062119
Timepoint [12] 0 0
Pre-dose on Cycle 1 Day 1 and Day 15; Day 1 of Cycles 2 to 4; Day 1 of every 3rd cycle since Cycle 5
Secondary outcome [13] 0 0
Incidence of ADA Positive Against PF-06801591
Timepoint [13] 0 0
Cycle 1 Day 1 and Day 15, Cycle 2 Day 1 and Day 15, Cycle 3 Day 1 and Day 15, Cycle 4 Day 15, Cycle 5 Day 15 and End of Treatment
Secondary outcome [14] 0 0
Percent Change From Baseline in Immune Biomarkers (CD3+ and CD8+ Cells/mm2 CT+, PD-L1 Tumor Cell Membrane Staining and PD-L1 Positive Immune Cells Per Tumor Area) in Pre-treatment and On-Treatment Paired Tumor Biopsies
Timepoint [14] 0 0
Baseline (Baseline was defined as the time closest to, but prior to, the start of study drug administration in the first cycle), Cycle 3 Day 1
Secondary outcome [15] 0 0
Number of Participants With Confirmed Objective Response
Timepoint [15] 0 0
Baseline up to maximum of 4 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2023
Sample size
Target
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Japan
State/province [7] 0 0
Chiba
Country [8] 0 0
Japan
State/province [8] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04171141