A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma

Advanced Urothelial Carcinoma Clinical Trial

Official title:

A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04603846
• Other study ID #: NTL-LEES-2019-06
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 10, 2020
• Est. completion date: August 25, 2023

Study information

• Verified date: January 2022
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with Albumin-bound paclitaxel in the treatment of Advanced urothelial carcinoma

Description:

This trial is designed to first include 6 subjects to confirm the dose safety. If the toxicity is intolerable, the dose of chemotherapeutic drugs will be reduced depending on the toxicity for further exploration.If it was tolerated, the recommended dose was determined, and the dose was extended. 14 patients were enrolled to further observe the safety and efficacy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 25, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old;
• Pathologically confirmed urothelial carcinoma;
• Terminal patients who have not received treatment or for the first time recurrence more than 6 months after the end of adjuvant chemotherapy after surgery;
• Evaluable lesions based on RECIST V1.1;
• ECOG score 0-1;
• Estimated life expectancy >3 months;
• The function of important organs meets the following requirements;
• The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

• Previously received drugs targeting PD-1, PD-L1, PD-L2 or other treatments targeting T cell costimulation or checkpoint channels;
• Received systemic corticosteroid immunosuppressants 2 weeks before the study;
• Suffer from active meningeal metastasis or uncontrolled, untreated brain metastasis;
• Severe cardiovascular disease, such as New York Heart Association (New York Heart Association,NYHA standard) Grade 3-4 heart failure, unstable angina pectoris, unstable arrhythmia, or color heart photo indicates LVEF (left ventricular ejection fraction) < 50%;
• Previous hypersensitivity to monoclonal antibodies;
• The patient has known, active or suspected autoimmune diseases. The following conditions are allowed: skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), type I diabetes, autoimmune hypothyroidism with hormone replacement therapy;
• The study drug suffered from other active malignant tumors within 5 years before the first use of the drug. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., can be included in the group;
• Active hepatitis B or C (unless HBV-DNA titer < 500IU/mL or copy number < 1000copies/ml, HCV-RNA negative after antiviral treatment can be included in), HIV positive or known history of acquired immunodeficiency syndrome;
• Severe infection existed before screening, including but not limited to, infections requiring hospitalization, bacteremia, severe pneumonia, etc;
• There has been active pulmonary tuberculosis in the past year, whether treated or not;
• Live attenuated vaccine was used within 28 days prior to screening;
• Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;
• Have received any other experimental drug treatment within 28 days prior to signing ICF;
• Pregnant or lactating women;
• Patients of childbearing age who refuse to use effective contraception;
• Other researchers believe that it is not suitable to join the group.

Related Conditions & MeSH terms

• Advanced Urothelial Carcinoma
• Carcinoma
• Carcinoma, Transitional Cell

Intervention

Drug:
• anti-PD-L1 antibody
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
• albumin bound paclitaxel
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .

Locations

Country	Name	City	State
China	Beijing Tumor Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	Adverse events of level 3 or above related to the study drug occurring within 21 days after the first dose as assessed by CTCAE v5.0.	21 days after first dose
Primary	Recommended phase II dose (RP2D)	DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.	21 days after first dose
Secondary	objective response rate	Percentage of patients in partial and complete response	12 months
Secondary	progression free survival	time between first dose of study drug to disease progression	12 months
Secondary	PD-L1 expression	The positive rate of PD-L1 expression in tumor tissue.	12 months
Secondary	TMB expression	The positive rate of TMB expression in tumor tissue.	12 months