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New treatment option for Non-Muscle-Invasive Bladder Cancer (NMIBC)
Official title A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
ClinicalTrials.gov ID: NCT06351904
What this study is testing
What is RAG-01?
RAG-01 is an investigational medicine, being studied as a potential treatment for non-muscle-invasive bladder cancer (nmibc).
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 an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy.
- Phase 1: an early, usually small safety study
- 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 to 75
You may be able to join if
- Ability to understand the study and have signed the informed consent form;
- Any adult ≥ 18 years old;
- Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;
- Expected survival ≥ 6 months;
- ECOG PS ≤2;
You likely can't join if
- Subject who is allergy to RAG-01 or similar products;
- Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is...
- Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra;
- Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of...
- The following illnesses have not been relieved to CTCAE 0-1:
- Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection;
See the full eligibility criteria
- Ability to understand the study and have signed the informed consent form;
- Any adult ≥ 18 years old;
- Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;
- Expected survival ≥ 6 months;
- ECOG PS ≤2;
- Sufficient organ functions, as defined below: Investigations Hematology Absolute Neutrophil Count (ANC): ≥ 1.5 x 109/L Hemoglobin: ≥ 90 g/L Platelet: ≥ 100 x 109/L Liver Function Serum bilirubin: ≤ 1.25×ULN or...
- Subject must be able to tolerate catheterization;
- Female subject of childbearing potential and her spouse must use adopt effective contraception (non-pharmacological contraception required) from signing informed consent to within 6 months after the last instillation;
- Subject who is allergy to RAG-01 or similar products;
- Except for TURBT, the subject received other anti-tumor treatments, and the last administration date is within ≤ 21 days or 5 half-lifes whichever is shorter from the date of signing ICF;
- Subject with imaging examination diagnosed extravesical metastasis, including ureter and urethra;
- Subject has other malignancies within the past 3 years, except for adequately treated carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or adenocarcinoma of the prostate that has been surgically...
- The following illnesses have not been relieved to CTCAE 0-1:
- Uncontrolled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection;
- Dyspnea;
- Acute and chronic kidney injury, and inflammation;
- Urinary incontinence;
- Urinary frequency;
- Urinary tract obstruction (except benign prostatic hypertrophy);
- Subject could not hold the urine for at least 90 mins due to any reason;
- New York Heart Association (NYHA) 3 or 4 grade;
- Coronary heart disease related symptoms have not been relieved to CTCAE 0-1, including: myocardial infarction, unstable angina pectoris, congestive heart failure and arrhythmia;
- Subject with QTc \>470 msec.
- Cerebrovascular accidents have not been relieved to CTCAE 0-1;
- HIV positive; Active hepatitis B or C. For active HBV, it's defined as HBsAg positive with HBV DNA ≥ ULN, for active HCV, it's defined as HCV antibody positive with HCV RNA ≥ ULN, respectively.
- Subject is pregnant or lactating during the treatment period;
- History of central nervous system or psychiatric disorders, e.g., epilepsy or dementia;
- Other severe systemic diseases which might compromise the subject's compliance to the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal diseases;
- Any other situations which are judged by the investigator, would exposure the subject to unnecessary risk, therefore he/she is not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- St Leonards, New South Wales, Australia
- Melbourne, Victoria, Australia
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include St Leonards, New South Wales, Australia; Melbourne, Victoria, Australia. 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.