Actively Recruiting
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
Led by Baylor College of Medicine · Updated on 2026-02-06
45
Participants Needed
1
Research Sites
941 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed advanced refractory HER2 positive solid tumors including head and neck, salivary gland, lung, breast, bladder, gastric, esophageal, colorectal, and pancreatic cancers
- HER2 positivity defined as 2+ or higher staining by immunohistochemistry in more than 10% of tumor cells
- Disease unsuitable for curative treatments such as surgery, radiotherapy, or systemic therapies
- Disease progressed after standard first line therapy or no effective treatment options available
- At least one tumor site appropriate for intratumoral injection
- Radiographically measurable disease according to RECIST 1.1
- Life expectancy greater than 12 weeks
- Able to understand and provide informed consent
- Adequate organ function as specified within 7 days prior to treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Prior HER2 targeted therapy allowed if given at least 4 weeks prior to enrollment (excluding dose levels 1 and 2)
- Women of childbearing potential must have negative pregnancy test and agree to use contraception
- Male participants with female partners of childbearing potential must agree to use barrier contraception
You will not qualify if you...
- Active autoimmune disease requiring continuous systemic corticosteroids over 10mg/day prednisone or equivalent, immunosuppressants, or other disease modifying agents
- Significant immunosuppressive conditions such as post organ transplant or HIV infection
- Diagnosis of other malignancies within the past 5 years except certain skin, thyroid, prostate, or cervical cancers
- Known active hepatitis B or C infection
- Acute myocardial infarction within 6 months prior to enrollment
- Injectable tumor site with significant risk of major hemorrhage (e.g., brain, pulmonary parenchyma, or near critical neurovascular structures)
- Uncontrolled intercurrent illness including psychiatric or social conditions affecting compliance
- Concurrent treatments that may interfere with the study including high dose corticosteroids, immunotherapy, or cytotoxic agents (with some exceptions at lower dose levels)
- Abnormal left ventricular function (LVEF less than 55%)
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 1 location
1
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Shalini Makawita, MD
CONTACT
D
Dustin McFadden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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