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New treatment option for Nonmuscle-invasive Bladder Cancer
Official title A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC
ClinicalTrials.gov ID: NCT06971614
What this study is testing
What is T3011?
T3011 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for nonmuscle-invasive bladder cancer.
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 is a Phase II clinical study to evaluate the efficacy and safety of intravesical T3011 injection in participants with BCG-unresponsive high-risk NMIBC or BCG-exposed, chemotherapy-unresponsive intermediate/high-risk NMIBC.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Participants may enter the study only if they meet all the following criteria:
- Male or female, aged ≥18 years at the time of signing the ICF.
- The participants will need to meet the following criteria:
- Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis).
- During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and assigned by chance biopsy.
You likely can't join if
- Participants meeting any of the following criteria will not be allowed to participate in this study:
- Participants meet the following criteria:
- Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.
- Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.
- Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic...
- Having received radiotherapy within 2 weeks prior to investigational product.
See the full eligibility criteria
Who can join
- Participants may enter the study only if they meet all the following criteria:
- Male or female, aged ≥18 years at the time of signing the ICF.
- The participants will need to meet the following criteria:
- Participants with a histologically confirmed diagnosis of NMIBC (Ta, T1 and/or Cis).
- During the study, the participants must voluntarily comply with the study-specified cystoscopy, urine cytology and assigned by chance biopsy.
- All toxicities caused by prior radiotherapy, chemotherapy or other treatments have recovered to Grade ≤1 (CTCAE 5.0) (except for alopecia), including but not limited to urinary tract infection, urinary tract irritation...
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival ≥24 weeks.
- Laboratory test values meeting the following requirements :
- Hematology ANC≥1.5×10\^9/L. PLT count ≥75×10\^9/L. Hemoglobin (HGB) ≥90 g/L.
- Renal function Creatinine clearance ≥60 mL/min (based on Cockcroft-Gault equation for calculation)
- Hepatic function Serum total bilirubin (TBIL) ≤1.5×ULN. Asparate aminotransferase (AST) and alanine transaminase (ALT) ≤2.5×ULN Serum ALB ≥30 g/L.
- Coagulation function International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN. Activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- For women of childbearing potential (WOCBP), the serum pregnancy test prior to the first dose must be negative and the potential participant must promise to use medically acceptable and effective methods of...
- Male participants of child-bearing potential must agree to use medically acceptable and effective methods of contraception after signing the ICF until at least 6 months after the last dose; in addition, male potential...
- Participants who understand and voluntarily sign the written ICF and are willing and able to comply with all trial requirements.
What rules you out
- Participants meeting any of the following criteria will not be allowed to participate in this study:
- Participants meet the following criteria:
- Concurrent or prior history of muscle-invasive (muscularis propria) or metastatic bladder cancer.
- Urothelial carcinoma of the upper genitourinary tract or prostatic urethra within 24 months prior to investigational product.
- Having received chemotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, investigational product or other anti-neoplastic therapies within 4 weeks prior to investigational product.
- Having received radiotherapy within 2 weeks prior to investigational product.
- Planning to receive any anti-neoplastic therapy other than the investigational products during this study.
- A history of allergic reactions to HSV-1, IL-12, or anti-PD-1 antibodies or biological components similar to them, or known allergic reactions to any component of the T3011 formulation.
- A history of brain metastasis or imaging-confirmed brain metastasis , leptomeningeal disease, or spinal cord compression.
- Concurrent or prior history of other malignancies than that treated in this study.
- History or evidence of high-risk cardiovascular diseases, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities.
- Acute myocardial infarction, unstable angina, or stroke, etc., developing within 6 months prior to the first dose of the investigational products.
- Coronary angioplasty or stenting within 6 months prior to the first dose of the investigational products.
- New York Heart Association (NYHA) criteria-defined cardiac function \> Class II; echocardiogram-documented cardiac valve morphological abnormalities (Grade ≥2).
- Left ventricular ejection fraction (LVEF) ˂lower limit of normal (LLN) of the study site, or ˂ 50% if no LLN is set at the site.
- Poorly controlled blood pressure .
- The following prior or concurrent immune disorders that in the investigator's opinion would pose unpredictable risks to the participants:
- Immune-related pneumonia or other immune-related adverse reactions of Grade ≥3 developing with prior immunotherapy (including but not limited to PD-1/PD-L1).
- Concurrent active immune diseases requiring treatment with systemic immunosuppressants (excluding autoimmune diseases not requiring intervention such as vitiligo and diseases treatable by other alternative drugs such as...
- Other concurrent diseases require treatment with systemic immunosuppressants.
- Unexplainable fever \>38.5℃ during the screening or on the day of treatment (fever judged as tumor-induced by the investigator is eligible for enrollment) that in the investigator's opinion will affect the participation...
- The following persistent or active infections: human immunodeficiency virus (HIV) antibody-positive, hepatitis B surface antigen [HBsAg] positive with HBV DNA level ≥2000 IU/mL, hepatitis C virus (HCV) antibody positive...
- Prior history of splenectomy or organ transplantation.
- Having previously received treatment with oncolytic virus (e.g., T-VEC, CG0070).
- Requiring oral or intravenous use of anti-herpes virus drugs, including but not limited to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir (except for those to be used locally...
- Participants with known psychiatric disorders that may affect compliance in trial or with poor compliance.
- Participants with a history of drug abuse (including "recreational use") or substance abuse (including alcohol) within one year prior to signing ICF.
- Being pregnant or breast feeding, or planning to become pregnant or give birth during this trial.
- Having received any live attenuated vaccine within 4 weeks prior to investigational product or planning to receive such vaccines during the study.
- Having undergone a major surgery.
- Any diseases that at the investigator's discretion may confound the trial results, interfere with the participation in the entire trial, and/or would make participating in the trial not in the participant's best...
The study team makes the final eligibility decision.
Where it's taking place
- Queen Creek, Arizona, United States
- Tampa, Florida, 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 Queen Creek, Arizona, United States; Tampa, Florida, 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.