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New treatment option for Bladder Cancer
Official title Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors
ClinicalTrials.gov ID: NCT03740256
What this study is testing
What is CAdVEC?
CAdVEC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Also referred to as HER2-specificCAR- T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- This study will look at solid tumors (as a basket trial for any solid cancer) with HER2 positivity based on IHC Procurement 1. The patient has a...
- The disease must be deemed unsuitable for curative treatments including surgery, radiotherapy, systemic therapy, including checkpoint inhibitors, or...
- Disease must have progressed after standard first line therapy, or without available effective treatment options. Patients are still eligible if they...
- 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.
You likely can't join if
- History or evidence of active autoimmune disease requiring continuous systemic corticosteroids (with more than 10mg/day prednisone or equivalent...
- 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...
- Patients with known active hepatitis B or C infection.
See the full eligibility criteria
Who can join
- This study will look at solid tumors (as a basket trial for any solid cancer) with HER2 positivity based on IHC Procurement 1. The patient has a histologically confirmed advanced refractory HER2 positive solid tumor...
- 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...
- 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.
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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 \ 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 people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.