BridgeMD
Tests treatment safety and results for High-risk Non-muscle Invasive Bladder Cancer
Official title 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
ClinicalTrials.gov ID: NCT06378242
What this study is testing
What is Disitamab Vedotin for injection?
Disitamab Vedotin for injection is an investigational medicine, being studied as a potential treatment for high-risk non-muscle invasive bladder cancer.
Also referred to as RC48.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is 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 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntary consent to participate in the study and signed the informed consent form.
- Male or female, age 18-75 years (including both).
- Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group...
- Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
- The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
You likely can't join if
- 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
- 2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
- 3\. Any other antitumor therapy received within 4 weeks before study administration, .
- 4 people plan to undergo major surgery during the study or within 4 weeks before the first dose.
- 5, Known allergic to DV and its components or to any excipients.
See the full eligibility criteria
- Voluntary consent to participate in the study and signed the informed consent form.
- Male or female, age 18-75 years (including both).
- Histologic confirmed non-muscle invasive bladder urothelial carcinoma (NMIBC), and the risk group met the high-risk (including very high-risk) group. Note: High-risk NMIBC is a high-grade / G3 tumor meeting any of the...
- Absence of resectable disease（Ta and/or T1 disease） after transurethral resection (TURBT) procedures (residual CIS acceptable;
- The urologist assessed that radical surgery for bladder cancer was not suitable or the subject refused radical surgery for bladder cancer.
- Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2 expression of 1+, 2+ or 3+.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate heart, bone marrow, liver, kidney and coagulation function
- 1\. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
- 2\. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
- 3\. Any other antitumor therapy received within 4 weeks before study administration, .
- 4 people plan to undergo major surgery during the study or within 4 weeks before the first dose.
- 5, Known allergic to DV and its components or to any excipients.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Wuhan, Hubei, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.