DISP-10 for advanced colorectal, gastric, and esophageal cancers
A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers
This trial will test a one-time combination of an engineered adenovirus (DV-10) and BCMA-directed CAR T cells (ide-cel) in adults with advanced colorectal, gastric, or esophageal cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dispatch Biotherapeutics Industry-sponsored |
| Drugs / interventions | cyclophosphamide, fludarabine, chimeric antigen receptor |
| Locations | 2 sites (Duarte, California and 1 other locations) |
| Trial ID | NCT07544589 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with advanced or metastatic colorectal, gastric, esophageal, or gastroesophageal adenocarcinoma who have measurable disease, at least one lesion amenable to biopsy, ECOG 0–1, and adequate organ function are the intended participants.
Not a fit: Patients with active CNS metastases, recent rapid disease progression, prior organ or hematopoietic cell transplant, active hepatitis B or HIV, significant effusions or peritoneal carcinomatosis, or those on antiviral therapy are unlikely to qualify or receive benefit from this protocol.
Why it matters
Potential benefit: If successful, DISP-10 could produce meaningful and potentially durable tumor shrinkage for some patients with advanced GI cancers who have limited standard options.
How similar studies have performed: CAR T therapies have been highly successful in blood cancers but remain largely unproven in solid tumors, and combining an oncolytic adenovirus with CAR T cells is a relatively novel approach with limited clinical proof-of-concept so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Histologically confirmed advanced or metastatic esophageal, gastroesophageal junction, gastric adenocarcinoma, or colorectal adenocarcinoma 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
Where this trial is running
Duarte, California and 1 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Tennessee Oncology — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Dispatch Clinical
- Email: clinicaltrials@dispatchbio.com
- Phone: (215) 792-4699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.