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

High-risk Non-muscle Invasive Bladder Cancer Clinical Trial

Official title:

An 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378242
• Other study ID #: RC48-C029
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 23, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2024
• Source: RemeGen Co., Ltd.
• Contact: Hong Luo
• Phone: +8610-58075763
• Email: hong.luo[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2029
• Est. primary completion date: March 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• High-risk Non-muscle Invasive Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Disitamab Vedotin for injection
Intravesical instiliations into the bladder

Locations

Country	Name	City	State
China	Hunan Cancer hospital	Changsha	Hunan
China	Sun Yat-sen Memorial Hospital,SunYat-sen University	Guangzhou	Guangdong
China	Shandong Cancer hospital & Institute	Jinan	Shangdong
China	The first affiliated hospital with nanjing medical universtity	Nanjing	Jiangsu
China	The first affiliated hospital withXi'an Jiao Tong Universtity	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicity(DLT) (Phase I)		Approximately 21 days
Primary	Incidence of Adverse event (Phase I)	According to the NCI CTCAE V5.0, to evaluate safety including adverse event rate and adverse event grade	Approximately 1 years
Primary	Recommended Phase II Dose(RP2D)	Assessed based on the Incidence of DLT	Approximately 21 days
Primary	Maximum Tolerated Dosage(MTD)	Assessed based on the Incidence of DLT	Approximately 21 days
Secondary	Disease-free survival (DFS) rates	Disease-free survival (DFS) rates was defined as the time from the date of first study treatment to the time of the subject's first high-grade Ta, T1 of any grade, CIS lasting greater than or equal to 6 months, new carcinoma in situ (CIS), cystectomy, disease progression, or death from any cause	Up to approximately 2 years
Secondary	Duration of response (DOR)	Defined as the time from the start of the first assessment of CR to the first assessment of high grade Ta, any grade of T1, new CIS, disease progression, cystectomy, or death from any cause	Up to approximately 2 years
Secondary	Disitamab Vedotin anti-drug antibody (ADA)	The number and proportion of anti-drug antibody (ADA)-positive subjects were analyzed according to dose group and time point.	Up to approximately 2 years
Secondary	PK of enfortumab vedotin: Maximum concentration (Cmax)	Cmax will be recorded from the PK blood samples collected.	Approximately 1 years
Secondary	PK of enfortumab vedotin: Trough concentration (Ctrough)	Ctrough will be recorded from the PK blood samples collected.	Approximately 1 year