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New treatment option for Colorectal Cancer
Official title A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
ClinicalTrials.gov ID: NCT07544589
What this study is testing
What is DISP-10?
DISP-10 is an investigational medicine, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Cincinnati, Ohio, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.