- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603846
A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma
January 20, 2022 updated by: Lee's Pharmaceutical Limited
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100000
- Beijing Tumor Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Combined treatment group
All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 6 cycles of albumin-bound paclitaxel 260mg/m2 d1,q3w;
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Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Other Names:
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity (DLT)
Time Frame: 21 days after first dose
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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.
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21 days after first dose
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Recommended phase II dose (RP2D)
Time Frame: 21 days after first dose
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DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.
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21 days after first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate
Time Frame: 12 months
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Percentage of patients in partial and complete response
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12 months
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progression free survival
Time Frame: 12 months
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time between first dose of study drug to disease progression
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12 months
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PD-L1 expression
Time Frame: 12 months
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The positive rate of PD-L1 expression in tumor tissue.
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12 months
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TMB expression
Time Frame: 12 months
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The positive rate of TMB expression in tumor tissue.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 10, 2020
Primary Completion (ANTICIPATED)
October 1, 2022
Study Completion (ANTICIPATED)
August 25, 2023
Study Registration Dates
First Submitted
September 8, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (ACTUAL)
October 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Carcinoma, Transitional Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Antibodies
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- NTL-LEES-2019-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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