RecruitingPhase 1NCT06351904
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
A Phase Ⅰ, Open Label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
Sponsor
Ractigen Therapeutics.
Enrollment
72 participants
Start Date
Apr 3, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria9
- 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 2.5×ULN（with Gilbert syndrome） AST \& ALT: ≤ 2.5×ULN Renal Function Creatinine Clearance (Cockcroft-Gault equation): ≥ 30 mL/min
- 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;
Exclusion Criteria21
- 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 treated with a post-treatment PSA that is non-detectable;
- 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.
Interventions
DRUGRAG-01
RAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06351904
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