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

NCT06186414 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-01-15

No results posted yet for this study

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)

Conditions

  • Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions

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

Sponsors & Collaborators

  • Shanghai Xianxiang Medical Technology Co., Ltd.

    collaborator INDUSTRY

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2027-01-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186414 on ClinicalTrials.gov