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NCT03740256 · ClinicalTrials.gov registry record · Phase 1
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
A Phase 1 study of Breast Cancer and Lung Cancer, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03740256: Recruiting Phase 1 study of Breast Cancer and Lung Cancer, sponsored by Baylor College of Medicine.
NCT03740256 is a Phase 1 study of Breast Cancer and Lung Cancer that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 45 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03740256, a Phase 1 study of Breast Cancer and Lung Cancer, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer. This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cells called HER2 chimeric antigen receptor specific cytotoxic T lymphocytes (HER2 specific CAR T cells), in combination with intra-tumor injection of CAdVEC, an oncolytic adenovirus that is designed to help the immune system including HER2 specific CAR T cell react to the tumor. The study is looking at combining these two treatments together, because we think that the combination of treatments will work better than each treatment alone. We also hope to learn the best dose level of the treatments and whether or not it is safe to use them together. In this study, CAdVEC will be injected into participants tumor at one tumor site which is most easiest to reach. Once it infects the cancer cells, activation of the immune response will occur so it can attack and kill cancer cells. (This approach may have limited effects on the other tumor sites that have not received the oncolytic virus injection, so, patients will also receive specific T cells following the intratumor CAdVEC injection.) These T cells are special infection-fighting blood cells that can kill cells infected with viruses and tumor cells. Investigators want to see if these cells can survive in the blood and affect the tumor. Both CAdVEC and HER2-specific autologous CAR T are investigational products. They are not approved by the FDA.
Primary Outcome
Incidence of dose limiting toxicities (DLT) of CAdVEC intratumoral injection in combination with HER2.CAR AdVST cells in patients with advanced refractory HER2 positive solid tumors.
Conditions Studied
Interventions
- BIOLOGICAL CAdVEC
Study Locations (1)
Texas
- Baylor St. Luke's Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2038-12-30 |
| Phase | Phase 1 |
What NCT03740256 shows while recruiting
NCT03740256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which CAdVEC is the first listed.
NCT03740256 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03740256 about?
NCT03740256 is a clinical study titled "Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors". This study is a first in human Phase 1 study that involves patients with a type of cancer called HER2 (Human Epidermal Growth Factor Receptor 2) positive cancer. This study asks patients to volunteer to take part in a research study investigating the safety and efficacy of using special immune cell...
What is the current status of trial NCT03740256?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2020-12-14. Estimated completion is 2038-12-30.
What conditions does trial NCT03740256 study?
This clinical trial studies the following conditions: Breast Cancer, Lung Cancer, Colorectal Cancer, Solid Tumor, Bladder Cancer.
What interventions are being tested in trial NCT03740256?
The interventions under investigation include: CAdVEC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03740256?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03740256 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT03740256's enrollment target sits among peer trials
45 843rd of 1224 higher than 374 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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