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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171141
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Gastrointestinal Tumors Colorectal Adenocarcinomas Gastric Adenocarcinomas Esophageal Adenocarcinomas Drug: PF-07062119 Drug: Anti-PD1 Drug: Anti-VEGF Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : February 8, 2025
Estimated Study Completion Date : February 8, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Single Agent Dose Escalation
 Drug: PF-07062119
PF-07062119
Experimental: Dose Finding Anti-PD-1 Combination
Part 1B PF-07062119 plus anti-PD-1
 Drug: PF-07062119
PF-07062119

Drug: Anti-PD1
Anti-PD1 PF-06801591
Experimental: Dose Finding anti-VEGF Combination
Part 1B PF-07062119 plus anti-VEGF
 Drug: PF-07062119
PF-07062119

Drug: Anti-VEGF
Anti-VEGF IV (bevacizumab)
Experimental: Dose Expansion Arm A
PF-07062119 as a Single Agent in CRC
 Drug: PF-07062119
PF-07062119
Experimental: Dose Expansion Arm B
PF-07062119 in Combination with anti-PD-1 in CRC
 Drug: PF-07062119
PF-07062119
Experimental: Dose Expansion Arm C
PF-07062119 in Combination with anti-VEGF in CRC
 Drug: PF-07062119
PF-07062119

Drug: Anti-PD1
Anti-PD1 PF-06801591

Drug: Anti-VEGF
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
 Drug: PF-07062119
PF-07062119

Drug: Anti-PD1
Anti-PD1 PF-06801591

Drug: Anti-VEGF
Anti-VEGF IV (bevacizumab)


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with Dose-limiting toxicities (DLT) in Cycle 1 [ Time Frame: Baseline up to 28 days (or 42 days as applicable) ]
  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to approximately 24 months ]
  3. Duration of Adverse Events (AEs) [ Time Frame: Baseline up to approximately 24 months ]
  4. Number of Participants With Adverse Events (AEs) According to Severity [ Time Frame: Baseline up to approximately 24 months ]
  5. Number of Participants With Adverse Events (AEs) According to Seriousness [ Time Frame: Baseline up to up to approximately 24 months ]
  6. Number of Participants With Adverse Events (AEs) by Relationship [ Time Frame: Baseline up to approximately 24 months ]
  7. 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 Measures :
  1. 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 ]
  2. Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119 [ Time Frame: Up to approximately 24 months ]
  3. Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1 [ Time Frame: Up to approximately 24 months ]
  4. Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF [ Time Frame: Up to approximately 24 months ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Objective Response - Number of Participants With Objective Response for Dose Escalation [ Time Frame: Baseline up to 24 months ]
  11. Objective Response - Number of Participants With Objective Response for Dose Finding portion [ Time Frame: Baseline up to 24 months ]
  12. 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 ]
  13. Progression-Free Survival (PFS) for Dose Expansion [ Time Frame: Baseline to measured progressive disease (up to 24 months) ]
  14. Duration of Response (DR) for Dose Expansion [ Time Frame: Baseline up to approximately 24 months ]
  15. Change from baseline of immune cells from tumor biopsies [ Time Frame: Baseline and Cycle 2, Day 1 (each cycle is 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171141


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04171141    
Other Study ID Numbers: C3861001
GUCY2C ( Other Identifier: Alias Study Number )
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
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
Additional relevant MeSH terms:
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Adenocarcinoma
Digestive System Neoplasms
Gastrointestinal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases