Study on New Medicine PF-08634404 with Chemotherapy for Gastroesophageal Cancer

Sponsor: Pfizer

Sponsor score: 60

ClinicalTrials ID:NCT07392892

This clinical trial is exploring a new medicine, PF-08634404, combined with chemotherapy to treat gastroesophageal cancer that has spread locally or to other parts of the body. The study aims to determine the safety and effectiveness of this combination compared to existing treatments.

Patient Parameters

Program Overview

The purpose of this study is to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to people with gastroesophageal cancer that is either locally advanced or has spread to other parts of the body. The study is divided into two parts: the first part will assess the safety and response to the new medicine combined with chemotherapy, and the second part will compare this combination to another approved treatment to see which is more effective. Participants will receive treatment in cycles, which are repeated periods of medication administration.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of gastric, gastroesophageal junction, or esophageal adenocarcinoma.
  • Cancer must be locally advanced or have spread to other parts of the body.
  • Must be in good physical condition with an ECOG performance status of 0 or 1.
  • No previous treatment for advanced or metastatic cancer.
  • Must have healthy liver, kidney, and other organ functions.
  • Cancer must be HER-2 negative and PD-L1 positive based on local tests.

Exclusion Criteria

  • Cannot have active cancer spread to the brain or spinal cord.
  • Cannot have a high risk of bleeding or fistula.
  • Cannot have had major surgery or severe injury within 4 weeks before starting the study, or plan major surgery during the study.
  • Cannot have a history of organ or stem cell transplants.
  • Cannot have had significant bleeding events recently.
  • Cannot have serious heart disease or other major health issues within 6 months before starting the study.
  • Cannot have active autoimmune diseases needing treatment in the past 2 years.
  • Cannot have lung disease caused by drugs or other non-infectious sources.

Locations

FACILITYZIPCITYSTATE
Rocky Mountain Cancer Centers, LLP80012AuroraColorado
Rocky Mountain Cancer Centers, LLP80303BoulderColorado
Rocky Mountain Cancer Centers, LLP80112CentennialColorado
Rocky Mountain Cancer Centers, LLP80907Colorado SpringsColorado
Rocky Mountain Cancer Centers, LLP80923Colorado SpringsColorado
Rocky Mountain Cancer Centers, LLP80218DenverColorado
Rocky Mountain Cancer Centers, LLP80220DenverColorado
Rocky Mountain Cancer Centers, LLP80113EnglewoodColorado
Rocky Mountain Cancer Centers, LLP80228LakewoodColorado
Rocky Mountain Cancer Centers, LLP80120LittletonColorado

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