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; Chemotherapy

  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, or BTC (intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma (perihilar and distal).
  • Have advanced or metastatic disease with prior exposure to the standard of care therapies listed in the protocol, with either no ongoing meaningful clinical benefit or discontinuation due to unacceptable toxicity, and no remaining curative options (per investigator).
  • At least one measurable site or disease RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Aged ≥18 years at time of signing informed consent.
  • For BTC: Adequate biliary drainage if obstruction; no uncontrolled cholestasis.
  • Adequate organ function.
  • Meet reproductive status requirements: a. Must not be pregnant or breastfeeding b. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test at screening c. WOCBP and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception to prevent pregnancy and condom with spermicide during intercourse, for the duration of study treatment and for 12 months following the last dose of study treatment

• Exclusion Criteria

  Key Exclusion Criteria:
  • Previous solid organ or hematopoietic cell transplant.
  • For CRC: BRAF V600E, MSI-H, or HER2 expressing tumors (≠≠≥2+ by IHC, if HER2 2+ by IHC should be confirmed by FISH)
  • Evidence of rapid disease progression, defined as radiographic or clinical progression within 3 months of the most recent prior line of therapy.
  • High disease burden as evidenced by any of the following: a.Largest target lesion ≥ 4 cm or a total length of measurable lesions ≥ 12 cm (as measured by RECIST 1.1) b. > 30% tumor liver involvement as assessed by the Investigator c. Pulmonary lymphangitis carcinomatosis or widespread metastatic lung lesions
  • Known history of hepatitis B or HIV infection.
  • Symptoms of bowel obstruction such as nausea, vomiting, weight loss due to early satiety from peritoneal disease (> 10% weight loss in 6 weeks prior to study entry)
  • 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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