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NCT07001592 · ClinicalTrials.gov registry record · Phase 1
Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors
A Phase 1 study of Esophageal Cancer and Liver Cancer, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT07001592: Recruiting Phase 1 study of Esophageal Cancer and Liver Cancer, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
NCT07001592 is a Phase 1 study of Esophageal Cancer and Liver Cancer that is actively recruiting participants, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute). The registered enrollment target is 18 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07001592, a Phase 1 study of Esophageal Cancer and Liver Cancer, is actively recruiting participants, sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each level. vvDD-hIL2 is a genetically modified vaccinia virus, derived from the virus previously used for smallpox vaccination. The modification is intended to target and destroy tumors while minimizing harm to healthy tissues by stimulating the body's immune response. Participants will receive an injection of vvDD-hIL2 directly into their abdominal tumors at AHN West Penn. The study team will monitor for side effects and assess tumor response to the treatment. Active participation will last up to two months, involving seven clinic visits and approximately four lab visits at AHN West Penn Hospital. Visits will include standard of care procedures as well as study-specific tests and exams. Most visits will last one to two hours, with some extending to two to three hours. The drug administration day will require a twelve-hour visit. Effectiveness and side effects will be evaluated through blood draws, oral swabs, urinalysis and tissue biopsies. Tissue samples will be used for genomic analysis and stored for potential future research. Data collected may also be used for future research purposes. Previous human trials of vvDD-hIL2 have reported side effects such as pain, rash or inflammation at the injection site, low-grade fevers, flu-like symptoms, and fatigue. There is a rare risk of rash transmission to close contacts with skin openings, and information on limiting contact and managing rash development will be provided.
Primary Outcome
Measured by frequency and severity of adverse events (AEs) at each dose level as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Conditions Studied
Interventions
- BIOLOGICAL vvDD-hIL-2-RG-1
Study Locations (1)
Pennsylvania
- AHN West Penn Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2025-05-06 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)34 total trials
What NCT07001592 shows while recruiting
NCT07001592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which vvDD-hIL-2-RG-1 is the first listed.
NCT07001592 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT07001592 about?
NCT07001592 is a clinical study titled "Intra-tumoral (IT) Injection of vvDD-hIL2-2-RG-1 for Metastatic Gastrointestinal and Peritoneal Tumors". This research study aims to evaluate the safety and determine the optimal dose of a new experimental drug, vvDD-hIL2 (vaccinia virus double-deleted human interleukin 2), in patients with advanced abdominal cancer. The study will involve three dose levels, with three to six patients enrolled at each ...
What is the current status of trial NCT07001592?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2025-05-06. Estimated completion is 2028-05.
What conditions does trial NCT07001592 study?
This clinical trial studies the following conditions: Esophageal Cancer, Liver Cancer, Gastric Adenocarcinoma, Peritoneal Cancer, Peritoneal Carcinoma.
What interventions are being tested in trial NCT07001592?
The interventions under investigation include: vvDD-hIL-2-RG-1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07001592?
This trial is sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute), which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07001592 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07001592's enrollment target sits among peer trials
18 112th of 123 higher than 12 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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