66 Participants NeededMy employer runs this trial

DISP-10 for Gastrointestinal Cancer

Recruiting at 4 trial locations
DC
Overseen ByDispatch Clinical
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called DISP-10 for individuals with advanced gastrointestinal cancers, such as esophageal and gastric adenocarcinomas. The goal is to determine the safety and effectiveness of DISP-10, which combines a virus (DV-10) with a special type of immune cell therapy (CAR T cells). The trial consists of two parts to identify the optimal dose and assess its efficacy. Suitable participants include those with specific advanced GI cancers and at least one tumor that can be biopsied. As a Phase 1 trial, this research aims to understand how the treatment functions in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that active treatment with antiviral agents is not allowed, so you may need to stop those if applicable.

Is there any evidence suggesting that DISP-10 is likely to be safe for humans?

Research has shown that the DISP-10 treatment, which combines a virus targeting cancer cells and a cell therapy targeting a protein on these cells, is under study for safety in people with advanced gastrointestinal cancers. As a Phase 1 trial, the primary goal is to assess the treatment's safety and tolerability in humans.

In early studies with similar treatments, researchers often identify side effects and determine safe dose levels. While side effects may occur, they are closely monitored. These studies aim to find the right dose that balances effectiveness with safety. Although specific data on DISP-10 side effects is not yet available, similar therapies can sometimes cause reactions like fever or tiredness.

Since this is an early-phase trial, understanding that the treatment's safety is still under exploration is crucial. However, careful monitoring and gradual dose increases aim to ensure participant safety as much as possible.12345

Why do researchers think this study treatment might be promising for gastrointestinal cancer?

Unlike the standard treatments for gastrointestinal cancer, which often include surgery, chemotherapy, and radiation, DISP-10 offers a novel approach by combining a new active ingredient, DV-10, with ide-cel, a type of CAR-T cell therapy. Most traditional treatments target cancer cells directly, but DISP-10 works by enhancing the immune system's ability to fight cancer through genetically modified T-cells. Researchers are excited about DISP-10 because it could provide a more personalized and potentially more effective treatment option with fewer side effects than conventional therapies.

What evidence suggests that DISP-10 could be an effective treatment for gastrointestinal cancer?

Research has shown that DISP-10, which participants in this trial will receive, combines DV-10 (a type of virus) and idecabtagene vicleucel (a type of immune therapy). This immune therapy, known as CAR T-cell therapy, boosts the body's natural defenses to target and destroy cancer cells. Studies have found that these therapies can significantly shrink tumors in other types of cancer. Viruses like DV-10 deliver treatment directly into cancer cells, aiding in their destruction. Early evidence from similar treatments suggests they may slow cancer growth and improve patient outcomes. This combination aims to attack cancer cells in different ways, increasing the chances of success.13678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced or metastatic cancers of the esophagus, stomach, gastroesophageal junction, or colon/rectum. Participants must have cancer that can be measured and biopsied, good organ function, and be in generally good physical condition.

Inclusion Criteria

My organs are working well enough for treatment.
I am 18 years old or older.
I have advanced or metastatic cancer of the esophagus, stomach, or colon.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Evaluation of safety and tolerability of increasing dose levels of DISP-10 to establish the recommended dose for expansion

28 days

Dose-Expansion

Evaluation of safety and efficacy of DISP-10 in participants treated at the recommended dose for expansion

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • DISP-10

Trial Overview

The study is testing DISP-10—a combination of a virus-based therapy (DV-10) and CAR T-cell therapy (ide-cel)—in people with advanced GI cancers. The trial will first find a safe dose, then test how well it works at that dose.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DISP-10Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dispatch Biotherapeutics

Lead Sponsor

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

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