Other Clinical Trial - A Study of SHR-1501 Alone or in Combination With

Clinical Trial Summary

The study is to evaluate the safety and tolerability of SHR-1501 alone or in combination with BCG intravesical therapy in the patients with NMIBC, and to determine the RP2D of SHR-1501 in combination with BCG. To evaluate the preliminary efficacy of SHR-1501 alone or in combination with intravesical BCG in the treatment of NMIBC.

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05410730
Study type	Interventional
Source	Shanghai Hengrui Pharmaceutical Co., Ltd.
Contact	Wenliang Wang
Phone	+0518-81220121
Email	Wenliang.wang@hengrui.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	November 23, 2022
Completion date	May 2027

A Study of SHR-1501 Alone or in Combination With BCG in Subjects With NMIBC

Clinical Trial Summary

Clinical Trial Description

Study Design