A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers (NCT07544589) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
United States66 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
✕. 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
What they're measuring
1
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timeframe: 90 days (2 years for related Serious Adverse Events)
2
Incidence of Dose Limiting Toxicities (DLTs) [PART 1]
Timeframe: 28 days
3
Identification of the Recommended Dose for Expansion (RDE) [PART 1]