A Phase I Dose Escalation And Expansion Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics And Anti Tumor Activity Of PF-07062119 In Patients With Advanced Gastrointestinal Tumors

Study Identifier:
C3861001
CT.gov Identifier:
NCT04171141
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn

Considering participating in a START clinical trial?

Get Started

Study Summary

To study dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

To evaluate 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).

To find the highest dose of the investigational drug PF-07062119 that can be given safely in patients with advanced colorectal, esophageal, or gastric (stomach) cancers. PF-07062119 is a “bispecific antibody.”

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gastric
  • Bowel (Colorectal)
  • Esophageal
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Arm 1:
    • Read More
  • Drug: Drug: Anti-PD1
  • Drug: Drug: Anti-VEGF
  • Drug: 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 Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Gastric
    Bowel (Colorectal)
    Esophageal