A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
Recruiting · NCT07544589 · Interventional (participants receive a specific treatment) · Lead sponsor: Dispatch Biotherapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
- Key
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
- 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
Where it is running
3 locations listed across 3 US states.
- City of Hope - Duarte, California, United States
- University of Cincinnati Cancer Center - Cincinnati, Ohio, United States
- Tennessee Oncology - Nashville, Tennessee, United States