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Study of CAdVEC and HER2-Specific CAR T-cells for Advanced HER2-Positive Solid Tumors

This study is for people with advanced HER2-positive solid tumors, such as bladder, head and neck, salivary gland, lung, or breast cancer. It's testing a combination of two treatments: CAdVEC, an oncolytic adenovirus (a virus that infects and kills cancer cells), and HER2-specific CAR T-cells (special immune cells designed to find and kill HER2-positive cancer cells). Researchers believe combining these treatments might work better than using them alone. You would receive an injection of CAdVEC directly into your tumor, and then later, your own T-cells, which have been specially modified in the lab to target HER2, would be given back to you. The main goal is to see how safe this combination is and to identify any serious side effects.

Study design
This is a Phase 1 study, meaning it's one of the first times this treatment combination is being tested in people. It plans to enroll 45 participants and is an interventional study, meaning participants will receive a specific treatment.
What's involved
You will receive an injection of CAdVEC into your tumor, which may involve ultrasound guidance and possibly sedation. Blood samples will be taken, and your own T-cells will be collected, modified in a lab, and then given back to you.
Compensation
Not stated in the trial record.
Follow-up
The study will measure dose-limiting toxicities (serious side effects) for 4 weeks after the HER2.CAR AdVST infusion or 4 weeks + 3 days after the CAdVEC injection.

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NCT03740256

Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Baylor College of Medicine
~45 participants
Updated 2026-02-06 on ClinicalTrials.gov
What's tested:CAdVEC

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0
Measured over 4 weeks after the HER2.CAR AdVST infusion or 4 weeks + 3 days after the CAdVEC injection.

Conditions

Bladder Cancer
Head and Neck Squamous Cell Carcinoma
Cancer of the Salivary Gland
Lung Cancer
Breast Cancer
Gastric Cancer
Esophageal Cancer
Colorectal Cancer
Pancreatic Adenocarcinoma
Solid Tumor

Explore related trials

Bladder CarcinomaBreast CarcinomaColorectal CarcinomaEsophageal CarcinomaGastric CarcinomaHead and Neck Squamous Cell CarcinomaLung CarcinomaMalignant Salivary Gland NeoplasmPancreatic AdenocarcinomaSolid NeoplasmERBB2 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Shalini Makawita, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

Shalini Makawita, MD
[email protected]
832-957-6500
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hematologic: Absolute neutrophil count (ANC) ≥1.0 x 10\^9/l; Hemoglobin ≥7 g/dl; Platelet count ≥ 100 x 10\^9/l; PT or PTT ≤ 1.5 x ULN unless the subject is receiving anticoagulation.
Hepatic function: bilirubin \< 2 x ULN, and AST and ALT \< 3 x ULN
Renal Function: serum creatinine \<2 x the ULN or creatinine clearance \>60 mL/min. 7. Prior HER2 targeted therapy is allowed if delivered at least 4 weeks prior to the enrollment. (Excluding DL1 and DL2) 8. Eastern Cooperative Oncology Group (ECOG) performance status 2 or less (Appendix I). 9. Females of childbearing potential must have a negative pregnancy test and agree to use contraception during on-study protocol therapy, or deemed to be not able to get pregnant. 10. Male subjects with pregnant partner/female partner of childbearing potential agree to use barrier contraceptive during the study to minimize the risk of embryo-fetal exposure. 11. The patient is ≥ 18 years of age, and able to understand and give informed consent to study related procedures and treatments.

Exclusion

Post organ transplant.
Diagnosis of HIV or other immunodeficiency disorders. 3. Diagnosis of other malignancies within 5 years except for cutaneous basal cell or squamous cell carcinoma, well-differentiated thyroid cancer, or localized prostate cancer. 4. Patients with known active hepatitis B or C infection. 5. Patient has had acute myocardial infarction within 6 months prior to consent for procurement. 6. Injectable tumor site is considered to incur a significant risk of major hemorrhage (e.g. located in the CNS (brain), and proximal to critical neurovascular structures) per investigator's review. 7. Uncontrolled intercurrent illness including but not limited to psychiatric illness and or social situations that in the opinion of the investigator would compromise compliance of study requirements or put the patient at unacceptable risk.
Post organ transplant.
Diagnosis of HIV or other immunodeficiency disorders. 5. Diagnosis of other malignancies within 5 years except for cutaneous basal cell or squamous cell carcinoma, well-differentiated thyroid cancer, or localized prostate or cervical cancer. 6. Patients with known active infectious disease, such as hepatitis B or C infection. 7. Patient has had acute myocardial infarction within 6 months prior to enrollment for treatment. 8. Patients with abnormal left ventricular function (LVEF \<55%). 9. Injectable tumor site is considered to incur a significant risk of major hemorrhage (e.g. located in the CNS (brain), pulmonary parenchyma, and proximal to critical neurovascular structures). 10. Pregnant or breastfeeding females. 11. Uncontrolled intercurrent illness including but not limited to psychiatric illness and or social situations that in the opinion of the investigator would compromise compliance of study requirements or put the patient at unacceptable risk.

What this trial measures

  • Number of patients with dose limiting toxicity (DLT) by CTCAE 5.04 weeks after the HER2.CAR AdVST infusion or 4 weeks + 3 days after the CAdVEC injection.

    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.