Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RAG-01 · 1 trial · 1 indication
Event-Free Survival rate
| Arm | Type | Description |
|---|---|---|
| Cohort A - Safety Lead in and Randomized, Controlled Trial | EXPERIMENTAL | High-risk NMIBC patients will be enrolled in a safety lead-in phase to evaluate the safety, tolerability, and initial efficacy of RAG-01 as monotherapy and in combination with a chemotherapy agent, and to determine the recommended dose. Approximately 12-24 patients will be enrolled in this lead-in phase, and these patients will receive non-randomized treatment. Following completion of the safety assessment during the safety lead-in phase and confirmation of acceptable safety results, additional eligible patients will be enrolled into a randomized controlled phase. In the randomized phase, patients will be randomized 1:1 to either RAG-01 monotherapy or RAG-01 plus a chemotherapy agent. |
| Cohort B - Single group | EXPERIMENTAL | Intermediate-risk NMIBC patients will receive RAG-01 monotherapy. |
| Name | Type | Description |
|---|---|---|
| RAG-01 | DRUG | The RAG-01 will be administered as a single agent for evaluation the efficiency in intermediate-risk NMIBC patients. |
| RAG-01 and chemotherapy agent | DRUG | To evaluate the safety, tolerability, and efficacy of RAG-01 as monotherapy and in combination with a chemotherapy agent in high-risk NMIBC patients, determine the recommended dose, and assess the efficacy of monotherapy and combination therapy. |
Inclusion Criteria: 1. Voluntarily agrees to participate in this study and provides written informed consent prior to the initiation of any study-specific procedures. 2. Is aged ≥18 years at the time of signing the informed consent form (ICF). 3. Has histologically confirmed tumor tissue obtained w...