Clinical Trial 24258

• Overview

  Study Title:

  A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants with Advanced Gastrointestinal Cancers

  Summary:

  This is a Phase 1, multicenter, open-label study of DISP-10, a combination therapy consisting of DV-10 (adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed chimeric antigen receptor [CAR] T), in adult participants with advanced gastrointestinal (GI) cancers. The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). Part 1 of the study will evaluate the safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion (RDE); Part 2 will evaluate the safety and efficacy of DISP-10 in participants treated at the RDE.

  Objective:

  Primary Part 1 - To assess the safety and tolerability of the DISP-10 in participants with colorectal cancer (CRC) and esophageal, gastroesophageal junction, and gastric adenocarcinoma (EGA) - To select the recommended dose and regimen for expansion (RDE) of the DISP-10 Primary Part 2 - To assess the safety and efficacy of DISP-10 in participants with CRC and EGA treated at the RDE

• Treatments

  Therapies:

  Cell Therapy; Chemotheraphy

  Medications:

  Cyclophosphamide (); DV-10 (); Fludarabine (); Idecabtagene Vicleucel ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma.
  • Measurable disease according to RECIST v1.1 and at least 1 additional site of disease amenable to biopsy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Aged ≥18 years at time of signing informed consent.
  • Adequate organ function.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Previous solid organ or hematopoietic cell transplant.
  • Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy.
  • Known history of hepatitis B or HIV infection.
  • Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollment.
  • Known active central nervous system (CNS) metastases.
  • Clinically significant pleural or pericardial effusion or peritoneal carcinomatosis.
  • Active treatment with antiviral agents.
  • History of severe hypersensitivity to fludarabine or cyclophosphamide.
  • Prior therapies/treatments with oncolytic viruses or T cell derived cellular therapy.

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