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Trial Title:
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy
NCT ID:
NCT06351904
Condition:
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RAG-01
Description:
RAG-01 is a therapeutic small activating RNA (saRNA).
Arm group label:
RAG-01
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.
Detailed description:
The study is planned to include a "3+3" dose escalation phase. The primary study period
includes a screening period, a treatment and Dose-Limiting Toxicity (DLT) assessment
period, and a follow-up period.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand the study and have signed the informed consent form;
2. ≥ 18, ≤ 75 years old, male or female;
3. Pathologically confirmed high grade NMIBC defined as grade 2 or grade 3 disease;
4. Expected survival ≥ 6 months;
5. ECOG PS ≤2;
6. 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
7. Subject must be able to tolerate catheterization;
8. 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 Criteria:
1. Subject who is allergy to RAG-01 or similar products;
2. 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;
3. Subject with imaging examination diagnosed extravesical metastasis, including ureter
and urethra;
4. 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;
5. The following illnesses have not been relieved to CTCAE 0-1:
1. Uncontrolled acute and chronic infections, such as pneumonia, biliary tract
infection, hepatitis B virus infection and hepatitis C virus infection;
2. Dyspnea;
3. Acute and chronic kidney injury, and inflammation;
4. Urinary incontinence;
5. Urinary frequency;
6. Urinary tract obstruction (except benign prostatic hypertrophy);
6. Subject could not hold the urine for at least 90 mins due to any reason;
7. New York Heart Association (NYHA) 3 or 4 grade;
8. Coronary heart disease related symptoms have not been relieved to CTCAE 0-1,
including: myocardial infarction, unstable angina pectoris, congestive heart failure
and arrhythmia;
9. Subject with QTc >470 msec.
10. Cerebrovascular accidents have not been relieved to CTCAE 0-1;
11. 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.
12. Subject is pregnant or lactating during the treatment period;
13. History of central nervous system or psychiatric disorders, e.g., epilepsy or
dementia;
14. Other severe systemic diseases which might compromise the subject's compliance to
the study, e.g., uncontrolled diabetes, gastrointestinal disorders, and renal
diseases;
15. Any other situations which are judged by the investigator, would exposure the
subject to unnecessary risk, therefore he/she is not eligible.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
GenesisCare North Shore
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Laurence Krieger, MBCHB
Phone:
+61 2 8037 4100
Email:
laurence_krieger@hotmail.com
Facility:
Name:
The Royal Melbourne Hospital
Address:
City:
Melbourne
Zip:
3050
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Paul Anderson, MBBS FRACS
Phone:
0393427294
Email:
mr.paul.anderson@gmail.com
Facility:
Name:
Peninsula & South Eastern Haematology and Oncology Group
Address:
City:
Melbourne
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sanjeev Sewak, MBBS, ECFMG
Phone:
0397815244
Email:
sewaks01@yahoo.com
Start date:
April 3, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
Ractigen Therapeutics.
Agency class:
Other
Source:
Ractigen Therapeutics.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06351904
