Menu
Recruiting NCT07544589

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

Phase I Interventional Colorectal Cancer Gastric Adenocarcinoma Esophageal Adenocarcinoma Gastroesophageal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DISP-10.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Gastric Adenocarcinoma, Esophageal Adenocarcinoma, Gastroesophageal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological DISP-10
    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce ide-cel. During ide-cel production, participants may receive bridging therapy for disease control per Investigator discretion. DV-10 administration will be followed by lymphodepleting chemotherapy (fludarabine and cyclophosphamide) and subsequent ide-cel administration.

Primary outcome measures

  • Incidence of Treatment Emergent Adverse Events (TEAEs) [Time frame: 90 days (2 years for related Serious Adverse Events)]
  • Incidence of Dose Limiting Toxicities (DLTs) [PART 1] [Time frame: 28 days]
  • Identification of the Recommended Dose for Expansion (RDE) [PART 1] [Time frame: Up to 2 years]
  • Overall response rate (ORR) [PART 2] [Time frame: Up to 2 years]
Secondary outcome measures (10)
  • Overall response rate (ORR) [PART 1] [Time frame: Up to 2 years]
  • Disease control rate (DCR) [Time frame: Up to 2 years]
  • Duration of response (DOR) [Time frame: Up to 2 years]
  • Progression Free Survival (PFS) [Time frame: Up to 2 years]
  • Overall survival (OS) [Time frame: Up to 15 years]
  • Time to response (TTR) [Time frame: Up to 2 years]
  • Cellular kinetics (CK) of ide-cel [Time frame: Up to 2 years]
  • Pharmacokinetics of DV-10 - Cmax [Time frame: Up to 2 years]
  • Pharmacokinetics of DV-10 - Tmax [Time frame: Up to 2 years]
  • Pharmacokinetics of DV-10 - AUC [Time frame: Up to 2 years]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • City of Hope — Duarte
  • University of Cincinnati Cancer Center — Cincinnati
  • Tennessee Oncology — Nashville

Identifiers

NCT: NCT07544589 · DISP-10-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗