Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine

NCT04799847 | Unknown Phase 1 DMC

• 1 other identifier: LP0190512
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 5

Brief Summary

A Multicenter, Non-randomized, Uncontrolled, Open-label Phase I/II study to Observe the Safety and Preliminary Efficacy of Catumaxomab in Patients with Non-Muscle-Invasive Bladder Cancer who have Failed or are Intolerant to Bacillus Calmette-Guerin (BCG) Vaccine

Conditions

Bladder Cancer

Keywords

Bladder Cancer; Failed or are Intolerant to BCG Vaccine; catumaxomab

Outcome Measures

Primary Outcomes (2)

• Dose escalation phase and dose expansion phase only: DLT incidence.

  Dose Limited Toxicity

  28 days

• 1-year recurrence rate since the initial instillation

  1-year recurrence rate since the initial instillation

  1 year

Secondary Outcomes (9)

• Recurrence rate at 3 months / 6 months / 2 years.

  Up to 2 years

• PFS

  2 years

• 2-year progression rate to MIBC.

  2 years

• The incidence and severity of treatment-emergent adverse events (TEAEs) and Serious adverse event（SAE）

  2 years

• ADA

  2 years

Study Arms (1)

Catumaxomab

EXPERIMENTAL

In the dose escalation phase, 2 dose levels of catumaxomab will be explored.

Drug: Catumaxomab

Interventions

Catumaxomab DRUG

This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 2 dose levels(20ug group and 100ug group）, in NMIBC patients are investigated.

Catumaxomab

Eligibility Criteria

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

You may qualify if:

• Signed and dated informed consent forms have been provided.
• Willing to be complaint with the study procedures during the study.
• Male or female, age ≥ 18 years old when signing informed consents.
• Histologically or cytologically diagnosed as NMIBC, i.e., bladder cancer in the following pTNM status: pTis, pTa, pT1.
• Have received the standard therapy recommended in the current NMIBC clinical guidelines, including intravesical BCG instillation, and diagnosed as BCG failure or intolerance.
• Participants had completed TURBT or cystoscopy as required by guidelines prior to enrollment, and no significant tumours were seen in the surgical field Residual lesions
• Recovered from any toxicity due to previous treatment (Grade 0-1 according to NCI-CTCAE v 5.0).
• Estimated life span is ≥ 6 months.
• Eastern Oncology Cooperative Group (ECOG) performance status 0-1.
• The laboratory test values during the screening period are in accordance with the following table:
• ANC(absolute neutrophil count)\>=1.5x10\^9/L
• Hemoglobin\>=80 g/L
• Platelet\>=100x10\^9/L
• Lymphocyte percentage\>=20%
• Serum Bilirubin \<=1.25

You may not qualify if:

• Known or suspected of being allergic to catumaxomab or similar antibodies.
• Besides the TURBT + immediate postoperative infusion chemotherapy for this NMIBC recurrence, participants received other anti-tumor treatments, including other anti-tumor investigational drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation therapy (excluding local radiation therapy for pain relief), etc., the interval between the last instillation and the first intravesical instillation is ≤ 21 days.
• Tumor metastases outside the bladder confirmed in imaging examination.
• With other primary malignant tumors diagnosed before the signing of ICF, excluding squamous cell carcinoma in situ of skin or cervical carcinoma in situ without recurrence within 5 years after resection.
• The following diseases have not been resolved to CTCAE grade 0-1 in 3 days prior to the first instillation:
• Uncontrolled acute and chronic infections such as pneumonia, biliary infection, hepatitis B virus infection and hepatitis C virus infection, etc.
• Dyspnea.
• Acute /chronic renal injury.
• Nephrotic syndrome.
• Bladder perforation.
• Urinary tract obstruction(except benign prostatic hypertrophy).
• NYHA Class 3 or 4.
• Related symptoms and signs of cardiovascular diseases have not been resolved to CTCAE grade 0-1: including myocardial infarction, congestive heart failure, and arrhythmia.
• Known cerebrovascular accidents have not been resolved to CTCAE grade 0-1.
• History of autoimmune diseases (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis, etc.).

Sponsors & Collaborators

• LintonPharm Co.,Ltd.: lead

Study Sites (5)

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

The Second Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

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

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 16, 2021
• Study Start: November 23, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

CN (5)