Trial NCT07544589
A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
- Phase
- Phase 1
- Sponsor
- Dispatch Biotherapeutics
- Conditions
- Colorectal Cancer; Gastric Adenocarcinoma; Esophageal Adenocarcinoma; Gastroesophageal Adenocarcinoma; Biliary Tract Carcinoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 1Performance status
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 infectionHIV
4. Previous or concurrent malignancy except if curatively treated more than 3 years prior to enrollmentPrior malignancy
5. Known active central nervous system (CNS) metastasesBrain 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.
Restrictions found (4)
- Brain metastasesOutrightexclusionShow in the text
- HIVConditionalexclusionShow in the text
- Performance statusConditionalinclusion
ECOG 0 or 1
Show in the text - Prior malignancyConditionalexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County