Other Clinical Trial - A Phase I Clinical Study of SHR-2005 Intravesical

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT03711032` - Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)	Phase 3
	Not yet recruiting	`NCT06378242` - To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2	Phase 1/Phase 2

See also

Status

Clinical Trial

Phase

Recruiting

NCT03711032 - Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

Phase 3

Not yet recruiting

NCT06378242 - To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2

Phase 1/Phase 2

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	NCT06108492
Study type	Interventional
Source	Shanghai Hengrui Pharmaceutical Co., Ltd.
Contact	Han Xu
Phone	0518-82342973
Email	Han.xu@hengrui.com
Status	Recruiting
Phase	Phase 1
Start date	November 28, 2023
Completion date	September 30, 2027

A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of High-risk Non-muscle Invasive Bladder Cancer (NMIBC)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms