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

NCT06378242 | Recruiting Phase 1

• 1 other identifier: RC48-C029
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

High-risk Non-muscle Invasive Bladder Cancer

Keywords

HER2-expression; High-risk non-muscle invasive bladder cancer; intravesical instiliations

Outcome Measures

Primary Outcomes (4)

• Incidence of dose-limiting toxicity(DLT) (Phase I)

  Approximately 21 days

• 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

• Recommended Phase II Dose(RP2D)

  Assessed based on the Incidence of DLT

  Approximately 21 days

• Maximum Tolerated Dosage(MTD)

  Assessed based on the Incidence of DLT

  Approximately 21 days

Secondary Outcomes (5)

• Disease-free survival (DFS) rates

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Disitamab Vedotin anti-drug antibody (ADA)

  Up to approximately 2 years

• PK of enfortumab vedotin: Maximum concentration (Cmax)

  Approximately 1 years

• PK of enfortumab vedotin: Trough concentration (Ctrough)

  Approximately 1 year

Study Arms (1)

Disitamab Vedotin Intravesical instiliations :Dose escalation cohort

EXPERIMENTAL

Participants will receive Disitamab Vedotin for injection Intravesical instiliations into the bladder for 1 hour, D1, once a week.

Drug: Disitamab Vedotin for injection

Interventions

Disitamab Vedotin for injection DRUG

Intravesical instiliations into the bladder

Also known as: RC48

Disitamab Vedotin Intravesical instiliations :Dose escalation cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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

You may not qualify if:

• \. Invasive bladder cancer (T2 and above) and / or with regional lymph node and distant metastasis.
• \. Combined urothelial carcinoma outside the bladder (i. e., urethra, ureter or renal pelvis).
• \. Any other antitumor therapy received within 4 weeks before study administration, .
• Subjects plan to undergo major surgery during the study or within 4 weeks before the first dose.
• , Known allergic to DV and its components or to any excipients.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (6)

Sun Yat-sen Memorial Hospital,SunYat-sen University

Guangzhou, Guangdong, China

RECRUITING

Tongji Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

The first affiliated hospital with nanjing medical universtity

Nanjing, Jiangsu, China

NOT YET RECRUITING

West China Hospital

Chengdu, Sichuan, China

NOT YET RECRUITING

Tianjin Medical University Second Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

Related Publications (1)

• Chen X, Huang M, Chen Z, Zhang C, Pan B, Liu C, Xu W, Fang J, Huang J, Lin T. Intravesical Disitamab Vedotin (RC48) for HER2-Expressing High-Risk Non-Muscle-Invasive Bladder Cancer: A Single-Arm, Dose-Escalation Phase I Trial Study. MedComm (2020). 2025 Jul 13;6(7):e70288. doi: 10.1002/mco2.70288. eCollection 2025 Jul.

  PMID: 40661136 DERIVED

MeSH Terms

Interventions

disitamab vedotin; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Hong Luo

CONTACT

+8610-58075763; hong.luo@remegen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 22, 2024
• Study Start: June 14, 2024
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CN (6)