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.
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;
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;
Single group
RAG-01
DrugRAG-01 is a therapeutic small activating RNA (saRNA) duplex molecule comprised of two partially chemically modified complementary oligonucleotide strands.
Safety and tolerability of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC)
Adverse events (AEs), serious adverse events (SAEs), and adverse events during treatment (TEAEs)
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of RAG-01
Dose-limiting toxicity (DLT)
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