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Closed (no longer recruiting)Last updated: 4 January 2024

This phase I trial is trying to understand how safe and tolerable a new targeted therapy drug (PF-07062119) is in people with selected advanced or metastatic gastrointestinal cancersA 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 summary

Summary

This is a non-randomised, multi-arm dose escalation and dose expansion 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). This study contains 2 parts, dose escalation with a single agent (Part 1A) and then dose finding with PF-07062119 in combination with anti-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).

Conditions

This trial is treating patients with colorectal, stomach and oesophageal cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Pfizer

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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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