NCT06186414

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC

An Open-Label, Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in Non-Muscle-Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

The study starts with a dose escalation part followed by a dose expansion part. The primary objective of the dose escalation part is to evaluate the safety and tolerability of SIM0237 alone or in combination with BCG, and determine the recommended dose(s) (RD). The primary objective of the dose expansion part is to evaluate the preliminary efficacy of SIM0237 alone or in combination with BCG.

Conditions

• Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DRUG	SIM0237	Several dose levels of SIM0237 will be administered as a single agent for evaluation
DRUG	SIM0237 and BCG	Several dose levels of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation
DRUG	SIM0237	RD level of SIM0237 will be administered as a single agent for evaluation
DRUG	SIM0237 and BCG	RD level of SIM0237 will be administered in combination with a fixed dose of BCG for evaluation

Timeline

• Start date: 2024-01-23
• Primary completion: 2027-01-01
• Completion: 2030-12-01
• First posted: 2024-01-02
• Last updated: 2025-01-15

Locations

14 sites across 1 country: China