Bladder CancerPhase 1VISTANCT03740256
Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
A Phase 1 study testing CAdVEC in people with Bladder Cancer and Head and Neck Squamous Cell Carcinoma, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland
- What is being tested?
- CAdVEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 30 Dec 2038
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will look at solid tumors (as a basket trial for any solid cancer) with HER2 positivity based on IHC
- Procurement Inclusion Criteria
- The patient has a histologically confirmed advanced refractory HER2 positive solid tumor, including but not limited to: head and neck squamous cell carcinoma; cancer of the salivary glands; lung cancer; breast cancer; bladder cancer; gastric cancer; esophageal cancer; colorectal cancer; and pancreatic adenocarcinoma. HER2 positivity is defined as ≥2+ staining by IHC with either the FDA-approved CB11 antibody (Leica) or anti HER2/neu (4B5) (VENTANA), which refers to greater than weak-to-moderate staining intensity in >10% tumor cells.
- The disease must be deemed unsuitable for curative treatments including surgery, radiotherapy, systemic therapy, including checkpoint inhibitors, or any combination of the above modalities by the referring oncology physician and confirmed by the senior oncologists leading the protocol.
- Disease must have progressed after standard first line therapy, or without available effective treatment options. Patients are still eligible if they have failed more than one line of therapy.
- The patient must have at least one tumor site appropriate for intratumoral injection.
Show all 48Show fewer
- The patient must have radiographically measurable disease as per RECIST 1.1.
- Life expectancy more than 12 weeks.
- The patient is ≥ 18 years of age, able to understand and give informed consent to study related procedures and treatments.
- Procurement Exclusion Criteria
- History or evidence of active autoimmune disease requiring continuous systemic corticosteroids (with more than 10mg/day prednisone or equivalent dose), immunosuppressants or other disease modifying agents (except palliative radiation).
- Evidence of significant immunosuppressive conditions, such as the following:
- Post organ transplant.
- Diagnosis of HIV or other immunodeficiency disorders.
- Diagnosis of other malignancies within 5 years except for cutaneous basal cell or squamous cell carcinoma, well-differentiated thyroid cancer, or localized prostate cancer.
- Patients with known active hepatitis B or C infection.
- Patient has had acute myocardial infarction within 6 months prior to consent for procurement.
- 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.
- 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.
- Treatment Inclusion Criteria:
- Histologically confirmed advanced refractory HER2 positive solid tumors, including but not limited to: head and neck squamous cell carcinoma; cancer of the salivary glands; lung cancer; breast cancer; bladder cancer; gastric cancer; esophageal cancer; colorectal cancer; and pancreatic adenocarcinoma. HER2 positivity is defined as ≥2+ staining by IHC with either the FDA-approved CB11 antibody (Leica) or anti HER2/neu (4B5) (VENTANA), which refers to greater than weak-to-moderate staining intensity in >10% tumor cells (HER2 positivity requirement is excluded in DL1 and DL2 as HER2 targeted agents are not used).
- The disease must be deemed unsuitable for curative treatments including surgery, radiotherapy, systemic therapy, including checkpoint inhibitors, or any combination of the above modalities by the referring oncology physician and confirmed by the senior oncologists leading the protocol.
- Disease must have progressed after standard first line therapy, or without available effective treatment options. Patients are still eligible if they have failed more than one line of therapy.
- The patient must have at least one tumor site appropriate for intratumoral injection.
- The patient must have radiographically measurable disease as per RECIST 1.1.
- The patient must have adequate organ function within 7 days prior to treatment as indicated by following measures:
- 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.
- Prior HER2 targeted therapy is allowed if delivered at least 4 weeks prior to the enrollment. (Excluding DL1 and DL2)
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less (Appendix I).
- 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.
- 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.
- The patient is ≥ 18 years of age, and able to understand and give informed consent to study related procedures and treatments.
- Treatment Exclusion Criteria:
- Patients with any concurrent treatment that would compromise the study including but not limited to continuous high dose corticosteroids (more than 10mg/day prednisone or equivalent dose), lympho-depleting antibodies, immunotherapy, targeted therapies or cytotoxic agents, CNS metastasis requiring continuous high-dose steroids (more than 10mg/day prednisone or equivalent dose) or other active therapeutic intervention. This does not include stable, previously-treated brain metastases. Patients on DL1 and DL2 can continue prior checkpoint inhibitors and HER2 targeted agents during the DLT evaluation period.
- Patients at significant risk of airway compromise or other critical obstruction (e.g. bowel, ureter, etc.) in the event of possible post injection tumor inflammation based on the investigative team's judgement.
- History or evidence of active autoimmune disease requiring continuous systemic corticosteroids, immunosuppressants or other disease modifying agents.
- Evidence of significant immunosuppressive conditions, such as the following:
- Post organ transplant.
- Diagnosis of HIV or other immunodeficiency disorders.
- 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.
- Patients with known active infectious disease, such as hepatitis B or C infection.
- Patient has had acute myocardial infarction within 6 months prior to enrollment for treatment.
- Patients with abnormal left ventricular function (LVEF <55%).
- 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).
- Pregnant or breastfeeding females.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Shalini Makawita, MD, 832-957-6500, Shalini.Makawita@bcm.edu
About this study
Official title: A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With 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 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.
Read more
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.
Read the detailed description
Treatment with CAdVEC:
On the first day of treatment, participants will receive an injection of CAdVEC into their tumor.
A blood sample will be obtained from the participant before the CAdVEC intratumor injection . Depending on the location of the tumor, different techniques can be used for the injection into your tumor. The most common route of injection is ultrasound-guided percutaneous (needle puncture in the skin) injection, but endoscopic (using a lighted, flexible instrument called an endoscope) ultrasound-guidance will be used for some patients as appropriate. Prior to percutaneous injection, participants may receive an anti-anxiety medicine to calm them down, to relieve muscle spasms, and provide sedation. If the participants tumor is injected during an endoscopic procedure, the procedure may be done under sedation.
Treatment with HER2- specific autologous T Cells:
The participant will have given blood earlier for us to make HER2 targeting cytotoxic T-lymphocytes (HER2- specific autologous T Cells). These cells are grown in the lab and frozen for participants. Investigators make the cells by combining dendritic cells (DCs) or monocytes with the T cells in the presence of produced mixtures of adenoviral proteins. Investigators then put a new gene in to those T cells to make them specifically attract to and kill HER2 positive tumors. As the T cells grow, they are cultured by adding adenoviral proteins for stimulation and expansion. Investigators call those T cells: HER2- targeting T cells (HER2- specific autologous T Cells).
This study looks at different doses of HER2- specific autologous T Cells. The decision about the dose participants receive is determined when enrolled on the study.
Five dose levels will be evaluated. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone on Day 1 or combined with an injection of HER2.CAR T cells on Day 4.
CAdVEC intratumoral injection will be given as a single injection to a single appropriate tumor site by direct, endoscopic, or image-guided injection on Day 1. After receiving the CAdVEC injection participants will be observed for 2-4 hours before leaving the hospital. During that time the study team will monitor vital signs and watch for any side-effects from the treatment. Participants will also be contacted by telephone about 24 hours after receiving the CAdVEC injection.
HER2.CAR T cells will be given intravenously on day 4 after CAdVEC injection, with a 3 day window (until day 7).
Before receiving the T cell infusion, participants may be given Benadryl (diphenhydramine) and Tylenol (acetaminophen). Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration. After receiving the infusion of HER2-specific autologous T cells participants will be observed for at least 3 hours before they may leave the hospital. Additionally, participants must plan to remain in the Houston area for at least 3 weeks after the infusion.
Standard medical tests before treatment:
Before being treated, participants will receive a series of standard medical tests and procedures as well as research blood draws.
Standard Medical tests during and after treatment:
During treatment, participants will receive standard medical tests and procedures as well as research blood draws.
Study specific evaluations:
Investigators will follow participants closely after treatment for any side effects for at least 2 years after the last infusion.
To learn more about the way the T cells are working in the body, an extra blood sample will be taken before the CAdVEC injection, before the CAR T cell infusion, and at week 1, 2, 4 , 6, months 3, 6, 9 and 12 after CAR T cell infusion. Thereafter every 6 months up to 5 years and then yearly for 15 years. Investigators will use this blood to see how long the T cells last and to look at the immune response to the cancer. Investigators may also obtain a tumor tissue biopsy before CAdVEC injection, between days 5 and 10 after infusion of the HER-2 CAR-T cells, and at the time tumor recurs. Urine will be collected before CAdVEC injection, Days 2, 4 (or the day of CAR T-cell infusion), weeks 1 and 2 after CAR T cell infusion.
- Conditions
- Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland, Lung Cancer, Breast Cancer, Gastric Cancer
- Being tested
- CAdVEC
- Keywords
- HER2, Human Epidermal Growth Factor Receptor 2, Bladder, Head and Neck Squamous Cell Carcinoma, Salivary Gland, Lung, Breast, Gastric, Esophageal, Colorectal, Pancreatic, Solid Tumor
- Medical subject headings
- Urinary Bladder Neoplasms, Squamous Cell Carcinoma of Head and Neck, Salivary Gland Neoplasms, Lung Neoplasms, Breast Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAdVECBiological
Also called HER2-specificCAR- T
The intratumoral administration of CAdVEC will create a pro-inflammatory tumor microenvironment and will promote the recruitment and expansion of adoptively transferred HER2 specific CAR T cells via CAR (tumor antigen). We expect HER2 CAR T cells expanded at primary tumor sites will re-circulate and target metastasized tumors. The combination we propose to test has the potential to overcome each of the established individual limitations of oncolytic viruses and of CAR T-cells. Testing each element separately would not be beneficial or informative, since the combination therapy is anticipated to have unique profiles of both therapeutic benefit and potential toxicities.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Phase | Experimental | Five dose levels will be evaluated using the BOIN design. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone on Day 1 or combined with an injection of HER2.CAR.T cells on Day 4, according to the following dose levels:
Dose Level 1 CAdVEC = 5.00E+9 HER2 specific CAR-T cells = 0
Dose Level 2 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 0
Dose Level 3 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+06
Dose Level 4 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+07
Dose Level 5 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+08 Receives: Biological: CAdVEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0
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.
Measured: 4 weeks after the HER2.CAR AdVST infusion or 4 weeks + 3 days after the CAdVEC injection.
Secondary outcomes (5)
Overall Response Rate (ORR) according to RECIST1.1 criteria
Overall response rate is defined as the number of patients experiencing PR or better (i.e. PR + CR) divided by the number evaluable for efficacy. Tumor regression or progression will be evaluated accordingly with RECIST 1.1 criteria.
Measured: 13 weeks
Disease Control Rate (DCR)
Disease Control Rate is defined as as the number of patients experiencing SD or better (i.e. SD+PR+CR) divided by the number evaluable for efficacy. Tumor regression or progression will be evaluated accordingly with RECIST 1.1 criteria.
Measured: 13 weeks
Progression Free Survival (PFS)
Progression-Free Survival is defined as the time from start of treatment to disease progression or death.
Measured: 15 years
Overall Survival (OS)
Overall survival is defined as the time from the start of treatment to death due to any cause.
Measured: 15 years
Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
Treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start14 Dec 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Shalini Makawita, Baylor College of Medicine
- Investigators
- Shalini Makawita, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740256
- Sponsor's protocol ID
- H-43405 VISTA
- Acronym
- VISTA
- Status last verified
- Feb 2026
- First submitted
- 9 Nov 2018
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT03740256
- Acronym / sponsor ID
- VISTA / H-43405 VISTA
- Conditions
- Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland, Lung Cancer, Breast Cancer, Gastric Cancer
- Keywords
- HER2, Human Epidermal Growth Factor Receptor 2, Bladder, Head and Neck Squamous Cell Carcinoma, Salivary Gland, Lung, Breast, Gastric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2038 (estimated)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment with CAdVEC:
On the first day of treatment, participants will receive an injection of CAdVEC into their tumor.
A blood sample will be obtained from the participant before the CAdVEC intratumor injection . Depending on the location of the tumor, different techniques can be used for the injection into your tumor. The most common route of injection is ultrasound-guided percutaneous (needle puncture in the skin) injection, but endoscopic (using a lighted, flexible instrument called an endoscope) ultrasound-guidance will be used for some patients as appropriate. Prior to percutaneous injection, participants may receive an anti-anxiety medicine to calm them down, to relieve muscle spasms, and provide sedation. If the participants tumor is injected during an endoscopic procedure, the procedure may be done under sedation.
Treatment with HER2- specific autologous T Cells:
The participant will have given blood earlier for us to make HER2 targeting cytotoxic T-lymphocytes (HER2- specific autologous T Cells). These cells are grown in the lab and frozen for participants. Investigators make the cells by combining dendritic cells (DCs) or monocytes with the T cells in the presence of produced mixtures of adenoviral proteins. Investigators then put a new gene in to those T cells to make them specifically attract to and kill HER2 positive tumors. As the T cells grow, they are cultured by adding adenoviral proteins for stimulation and expansion. Investigators call those T cells: HER2- targeting T cells (HER2- specific autologous T Cells).
This study looks at different doses of HER2- specific autologous T Cells. The decision about the dose participants receive is determined when enrolled on the study.
Five dose levels will be evaluated. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone on Day 1 or combined with an injection of HER2.CAR T cells on Day 4.
CAdVEC intratumoral injection will be given as a single injection to a single appropriate tumor site by direct, endoscopic, or image-guided injection on Day 1. After receiving the CAdVEC injection participants will be observed for 2-4 hours before leaving the hospital. During that time the study team will monitor vital signs and watch for any side-effects from the treatment. Participants will also be contacted by telephone about 24 hours after receiving the CAdVEC injection.
HER2.CAR T cells will be given intravenously on day 4 after CAdVEC injection, with a 3 day window (until day 7).
Before receiving the T cell infusion, participants may be given Benadryl (diphenhydramine) and Tylenol (acetaminophen). Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration. After receiving the infusion of HER2-specific autologous T cells participants will be observed for at least 3 hours before they may leave the hospital. Additionally, participants must plan to remain in the Houston area for at least 3 weeks after the infusion.
Standard medical tests before treatment:
Before being treated, participants will receive a series of standard medical tests and procedures as well as research blood draws.
Standard Medical tests during and after treatment:
During treatment, participants will receive standard medical tests and procedures as well as research blood draws.
Study specific evaluations:
Investigators will follow participants closely after treatment for any side effects for at least 2 years after the last infusion.
To learn more about the way the T cells are working in the body, an extra blood sample will be taken before the CAdVEC injection, before the CAR T cell infusion, and at week 1, 2, 4 , 6, months 3, 6, 9 and 12 after CAR T cell infusion. Thereafter every 6 months up to 5 years and then yearly for 15 years. Investigators will use this blood to see how long the T cells last and to look at the immune response to the cancer. Investigators may also obtain a tumor tissue biopsy before CAdVEC injection, between days 5 and 10 after infusion of the HER-2 CAR-T cells, and at the time tumor recurs. Urine will be collected before CAdVEC injection, Days 2, 4 (or the day of CAR T-cell infusion), weeks 1 and 2 after CAR T cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Phase | Experimental | Biological: CAdVECFive dose levels will be evaluated using the BOIN design. Cohorts of size 3 will be enrolled at each dose level until 9 evaluable patients have been studied at a single dose. Each patient will receive an intratumoral injection of CAdVEC alone on Day 1 or combined with an injection of HER2.CAR.T cells on Day 4, according to the following dose levels: Dose Level 1 CAdVEC = 5.00E+9 HER2 specific CAR-T cells = 0 Dose Level 2 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 0 Dose Level 3 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+06 Dose Level 4 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+07 Dose Level 5 CAdVEC = 1.00E+10 HER2 specific CAR-T cells = 1.00E+08 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (48 listed)
- This study will look at solid tumors (as a basket trial for any solid cancer) with HER2 positivity based on IHC
- Procurement Inclusion Criteria
- The patient has a histologically confirmed advanced refractory HER2 positive solid tumor, including but not limited to: head and neck squamous cell carcinoma; cancer of the salivary glands; lung cancer; breast cancer; bladder cancer; gastric cancer; esophageal cancer; colorectal cancer; and pancreatic adenocarcinoma. HER2 positivity is defined as ≥2+ staining by IHC with either the FDA-approved CB11 antibody (Leica) or anti HER2/neu (4B5) (VENTANA), which refers to greater than weak-to-moderate staining intensity in >10% tumor cells.
- The disease must be deemed unsuitable for curative treatments including surgery, radiotherapy, systemic therapy, including checkpoint inhibitors, or any combination of the above modalities by the referring oncology physician and confirmed by the senior oncologists leading the protocol.
- Disease must have progressed after standard first line therapy, or without available effective treatment options. Patients are still eligible if they have failed more than one line of therapy.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAdVECAlso: HER2-specificCAR- TThe intratumoral administration of CAdVEC will create a pro-inflammatory tumor microenvironment and will promote the recruitment and expansion of adoptively transferred HER2 specific CAR T cells via CAR (tumor antigen). We expect HER2 CAR T cells expanded at primary tumor sites will re-circulate and target metastasized tumors. The combination we propose to test has the potential to overcome each of the established individual limitations of oncolytic viruses and of CAR T-cells. Testing each element separately would not be beneficial or informative, since the combination therapy is anticipated to have unique profiles of both therapeutic benefit and potential toxicities. | Biological | Treatment Phase |
Primary outcome
Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0
Time frame: 4 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.
5 secondary outcomes
Overall Response Rate (ORR) according to RECIST1.1 criteria
Time frame: 13 weeks
Disease Control Rate (DCR)
Time frame: 13 weeks
Progression Free Survival (PFS)
Time frame: 15 years
Overall Survival (OS)
Time frame: 15 years
Number of treatment related adverse events with grade 3 or greater severity by CTCAE 5.0
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shalini Makawita, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAdVEC in people with Bladder Cancer and Head and Neck Squamous Cell Carcinoma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 48 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalini Makawita, MD (832-957-6500, Shalini.Makawita@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicity (DLT) by CTCAE 5.0 (time frame: 4 weeks after the HER2.CAR AdVST infusion or 4 weeks + 3 days after the CAdVEC injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.