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RecruitingPhase 1

A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers

A Phase 1 Study to Evaluate the Safety and Efficacy of DISP-10 in Participants With Advanced Gastrointestinal Cancers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests DISP-10 in adults with advanced cancers of the digestive system. DISP-10 combines a virus called DV-10 with ide-cel, a treatment made from immune cells called T cells. The study will find a dose to use and check its safety, side effects, and how well it works.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you agree to join.
  • A tissue test shows advanced or spreading cancer of the food pipe, where it meets the stomach, the stomach, the colon or rectum, or the bile ducts. Only certain cancer types qualify.
  • Your cancer can be measured using study rules, and another cancer site can be sampled for testing.
  • You can do all usual activities, or you have trouble only with hard physical activity.
  • Your organs work well enough for the study.

Who can't join

  • You have had an organ transplant or a transplant of blood-forming cells.
  • Scans or medical checks showed your cancer getting worse within 3 months of your most recent treatment.
  • You have a known history of hepatitis B or HIV infection.
  • You have another current or past cancer, unless it was treated to cure it more than 3 years before joining.
  • You have known active cancer spread to the brain or spinal cord.
  • You have a serious fluid buildup around the lungs or heart, or cancer spread in the lining of the belly.
  • You are taking medicine to treat viruses, or you have had a severe allergic reaction to fludarabine or cyclophosphamide.
  • You have had treatment with cancer-killing viruses or cell therapy made from T cells. Other study rules also apply; ask the study site.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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 Additional criteria apply and should be discussed with the study site.

Study sites (7)

CA

FL

MA

OH

TN

UT