DISP-10 for advanced colorectal, gastric, and esophageal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, multicenter, open-label trial of DISP-10, a combination of DV-10 (an adenovirus) and idecabtagene vicleucel (ide-cel, BCMA-directed CAR T). The study has two parts: a dose-escalation phase to find a recommended dose for expansion, followed by a dose-expansion phase to further study safety and preliminary efficacy at that dose. Eligible adults must have histologically confirmed advanced or metastatic colorectal, gastric, esophageal, or gastroesophageal adenocarcinoma with measurable disease and at least one site suitable for biopsy, an ECOG performance status of 0–1, and adequate organ function. Key exclusions include prior solid organ or stem-cell transplant, active hepatitis B or HIV, active CNS metastases, recent rapid progression, or significant effusions or peritoneal carcinomatosis.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Additional criteria apply and should be discussed with the study site.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Hoag Memorial Hospital Presbyterian
  Newport Beach, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• University of Cincinnati Cancer Center
  Cincinnati, Ohio, United States Recruiting
• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Dispatch Clinical
• Email: clinicaltrials@dispatchbio.com
• Phone: (215) 792-4699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.