Overview
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
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.
Eligibility
Inclusion 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 following:
a.Carcinoma in situ (CIS) b. T1 stage c. diameter>3cm d.Multiple tumors, or recurrent tumors.
- 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
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.