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.
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
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
Dispatch Biotherapeutics
Lead sponsor
Bristol-Myers Squibb
Collaborator