Study of Suratadenoturev (OBP-301) with Pembrolizumab for Esophagogastric Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06340711

Provider View

This clinical trial is testing a new treatment combining OBP-301 and pembrolizumab for advanced or metastatic gastric and gastroesophageal cancer. The study aims to find out if this combination is safe and effective.

Patient Parameters

Program Overview

The purpose of this study is to explore the effects of a new treatment using OBP-301 and pembrolizumab for patients with advanced gastric or gastroesophageal cancer. Participants will receive OBP-301 injections directly into the tumor every two weeks, along with pembrolizumab infusions every six weeks. The study will assess if this combination is safe and can help control the cancer.

Description

This study is for patients with advanced gastric, gastroesophageal junction, or esophageal cancer that has worsened after at least one previous treatment. Participants must have had prior immunotherapy. The study will test if adding OBP-301 to pembrolizumab can help patients who did not respond to initial immunotherapy.

Participants will receive OBP-301 injections directly into their tumors, followed by pembrolizumab infusions a few days later. OBP-301 injections will be given every two weeks for up to five treatments, while pembrolizumab will be given every six weeks until the cancer progresses.

The main goal is to see if the treatment can shrink tumors in at least 20% of patients. The study will also look at how long the response lasts and how long patients live without the cancer getting worse. In a previous study, some patients had positive responses lasting over 20 months.

The study will start with 13 patients. If no one responds, the study will stop. If there are responses, 14 more patients will be added, making a total of 27 participants.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic gastric, gastroesophageal junction, or esophageal cancer that can be injected with OBP-301 (tumor size at least 1 cm).
  • Tumor must be PD-L1 positive, meaning it has a certain marker that can be detected by a lab test.
  • Tumor must be HER2 negative, as confirmed by a lab test.

Exclusion Criteria

  • Currently in another study or received another study treatment within 3 weeks before starting this study.
  • Have an active autoimmune disease needing treatment in the past 2 years, except for hormone replacement.
  • Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive drugs within 7 days before starting the study.
  • Have active cancer spread to the brain or spinal fluid.
  • Have had recent cancer treatments or not recovered from side effects of previous treatments.
  • Have another active cancer within 3 years, except controlled prostate cancer.
  • Have received a live vaccine within 30 days before starting the study.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Have a history of lung disease needing steroids or current lung disease.
  • Have an active infection needing treatment within 2 weeks before starting the study.
  • Cannot follow study procedures.
  • Have severe allergies to monoclonal antibodies.
  • Have not recovered from major surgery or have ongoing complications.
  • Have had a tissue or organ transplant.
  • Have certain uncontrolled illnesses.
  • Are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the study.
  • Plan to father a child during the study.

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