This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with Non-Muscle-Invasive Bladder Cancer (NMIBC)
Written informed consent.
≥ 18 years of age, male or female.
• Histologically confirmed presence of BCG-unresponsive CIS (with or without Ta or T1 disease) or histologically confirmed presence of BCG-unresponsive high-grade Ta or T1 disease. Histologic confirmation of urothelial carcinoma (mixed histology tumors allowed if urothelial histology is predominant histology).
Dose escalation phase: BCG-unresponsive high-risk NMIBC.
• Subjects received TURBT or other surgical treatment for bladder lesions or pelvic radiotherapy or interventional therapy within 2 weeks prior to the first dose.
Previous treatment with: a) IL-15 or IL-2; b) immune checkpoint inhibitors (such as anti-PD-1 or PD-L1 antibodies), ADCs, chemotherapies, oncolytic viruses, BCG or other anti-tumor treatments, unless there is clear evidence of disease persistence/recurrence/progression after the above treatments and beyond 4 weeks prior to the first dose; c) Chinese herbal medicine treatment beyond 2 weeks prior to the first dose is allowed; d) A single immediate instillation of chemotherapy within 4 weeks prior to the first dose is allowed; e) intravesical instillation of mucosal protective agents (e.g., sodium hyaluronate) are allowed.
Subject is participating in an investigational drug or investigational device study.
Subjects have not recovered from AEs caused by previous anti-tumor treatment.
Sequential
SIM0237
DrugSeveral dose levels of SIM0237 will be administered as a single agent for evaluation
SIM0237 and BCG
DrugSeveral dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
SIM0237
DrugRD level of SIM0237 will be administered as a single agent for evaluation
SIM0237 and BCG
DrugRD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
6
Treatment groupsSee each treatment group below.
Dose escalation:Dose limited toxicity (DLT)
Dose escalation: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
Incidence and severity of adverse events (AEs) and serious adverse events(SAEs),and lab abnormalities
Dose expansion:Complete response (CR) rate at Month 3
Complete response (CR) rate at of Cohort 1 and Cohort 3
Dose escalation: Percentage of participants experiencing AE related dose interruptions and dose delays, dose intensity
Occurrence of AE related dose interruptions, dose delays and dose intensity
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Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianxiang Medical Technology Co., Ltd.
Collaborator
