Clinical Trials /

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

NCT04171141

Description:

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

Related Conditions:
  • Colorectal Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: C3861001
  • SECONDARY ID: GUCY2C
  • NCT ID: NCT04171141

Conditions

  • Gastrointestinal Tumors
  • Colorectal Adenocarcinomas
  • Gastric Adenocarcinomas
  • Esophageal Adenocarcinomas

Interventions

DrugSynonymsArms
PF-07062119Dose Escalation
Anti-PD1Dose Finding Anti-PD-1 Combination
Anti-VEGFDose Finding anti-VEGF Combination

Purpose

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).
    

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalSingle Agent Dose Escalation
  • PF-07062119
Dose Finding Anti-PD-1 CombinationExperimentalPart 1B PF-07062119 plus anti-PD-1
  • PF-07062119
  • Anti-PD1
Dose Finding anti-VEGF CombinationExperimentalPart 1B PF-07062119 plus anti-VEGF
  • PF-07062119
  • Anti-VEGF
Dose Expansion Arm AExperimentalPF-07062119 as a Single Agent in CRC
  • PF-07062119
Dose Expansion Arm BExperimentalPF-07062119 in Combination with anti-PD-1 in CRC
  • PF-07062119
Dose Expansion Arm CExperimentalPF-07062119 in Combination with anti-VEGF in CRC
  • PF-07062119
  • Anti-PD1
  • Anti-VEGF
Dose Expansion Arm DExperimentalPF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
  • PF-07062119
  • Anti-PD1
  • Anti-VEGF

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with Dose-limiting toxicities (DLT) in Cycle 1
Time Frame:Baseline up to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure:Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for PF-07062119
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies anti-PD1
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure:Incidence of Anti-Drug Antibody (ADA) an Neutralizing Antibodies (Nab) for anti-VEGF
Time Frame:Up to approximately 24 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Objective Response - Number of Participants With Objective Response for Dose Escalation
Time Frame:Baseline up to 24 months
Safety Issue:
Description:
Measure:Objective Response - Number of Participants With Objective Response for Dose Finding portion
Time Frame:Baseline up to 24 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) for Dose Expansion
Time Frame:Baseline to measured progressive disease (up to 24 months)
Safety Issue:
Description:
Measure:Duration of Response (DR) for Dose Expansion
Time Frame:Baseline up to approximately 24 months
Safety Issue:
Description:
Measure:Change from baseline of immune cells from tumor biopsies
Time Frame:Baseline and Cycle 2, Day 1 (each cycle is 28 days)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Trial 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

Last Updated

December 16, 2019