Trial 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
NCT ID:
NCT06378242
Condition:
High-risk Non-muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Disitamab vedotin
Conditions: Keywords:
HER2-expression
High-risk non-muscle invasive bladder cancer
intravesical instiliations
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin for injection
Description:
Intravesical instiliations into the bladder
Arm group label:
Disitamab Vedotin Intravesical instiliations :Dose escalation cohort
Other name:
RC48
Summary:
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
Detailed description:
This is a single-arm, multicenter phase I/II clinical study 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary consent to participate in the study and signed the informed consent form.
2. Male or female, age 18-75 years (including both).
3. 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 following:
a.Carcinoma in situ (CIS) b. T1 stage c. diameter>3cm d.Multiple tumors, or
recurrent tumors.
4. Absence of resectable disease（Ta and/or T1 disease） after transurethral resection
(TURBT) procedures (residual CIS acceptable;
5. The urologist assessed that radical surgery for bladder cancer was not suitable or
the subject refused radical surgery for bladder cancer.
6. Tumor tissue samples were detected by immunohistochemistry (IHC) to satisfy HER2
expression of 1+, 2+ or 3+.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
8. Adequate heart, bone marrow, liver, kidney and coagulation function
Exclusion Criteria:
-
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 Subjects 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital,SunYat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Tianxin Lin, Ph.D
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shaogang Wang, M.D
Facility:
Name:
Hunan Cancer hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusuan Jiang, M.D
Facility:
Name:
The first affiliated hospital with nanjing medical universtity
Address:
City:
Nanjing
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
qiang Lv, M.D
Facility:
Name:
West China Hospital
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Peng Zhang, M.D
Facility:
Name:
Tianjin Medical University Second Hospital
Address:
City:
Tianjin
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hailong Hu, M.D
Start date:
June 14, 2024
Completion date:
December 31, 2029
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378242
