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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603846
Recruitment Status : Active, not recruiting
First Posted : October 27, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Urothelial Carcinoma Drug: anti-PD-L1 antibody Drug: albumin bound paclitaxel Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : August 25, 2023

Resource links provided by the National Library of Medicine


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;
Drug: anti-PD-L1 antibody
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Other Name: ZKAB001

Drug: albumin bound paclitaxel
Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
Other Name: ABRAXANE




Primary Outcome Measures :
  1. Dose limiting toxicity (DLT) [ Time Frame: 21 days after first dose ]
    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.

  2. Recommended phase II dose (RP2D) [ Time Frame: 21 days after first dose ]
    DLT occurs in no more than 1/6 subjects, this dose is defined as RP2D.


Secondary Outcome Measures :
  1. objective response rate [ Time Frame: 12 months ]
    Percentage of patients in partial and complete response

  2. progression free survival [ Time Frame: 12 months ]
    time between first dose of study drug to disease progression

  3. PD-L1 expression [ Time Frame: 12 months ]
    The positive rate of PD-L1 expression in tumor tissue.

  4. TMB expression [ Time Frame: 12 months ]
    The positive rate of TMB expression in tumor tissue.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603846


Locations
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China, Beijing
Beijing Tumor Hospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Lee's Pharmaceutical Limited
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04603846    
Other Study ID Numbers: NTL-LEES-2019-06
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs