A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

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Brief Title

A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

Official Title

A Single-arm, Open-label,Phase Ib Clinical Study of ZKAB001 Combined With Capecitabine in Adjuvant Therapy for Patients With Biliary Tract Cancer After Radical Resection

Brief Summary

      This is a Phase Ib, open-label,single-arm, clinical study, aiming to investigate the safety,
      tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the
      Programmed Death - Ligand 1 (PD-L1) membrane receptor ) combined with capecitabine as
      adjuvant chemotherapy for patients with biliary tract cancers after radical resection.After
      completing 8 courses of combined treatment ,ZKAB001 was continued to be administered
      separately once 3 weeks for a total of 16 cycles or 1 year.
    

Detailed Description

      This study includes two phases,the first phase is the dose exploration, 6 subjects were first
      included at the initial dose to confirm the dose safety. If the toxicity is not tolerated,
      the dose of the chemotherapeutic agent will be reduced depending on the toxicity(including
      hematological toxicity and non-hematological toxicity) for further exploration. If it can be
      tolerated, the recommended dose is determined and expanded on this dose. the second phase is
      the dose expansion, 4 subjects will be enrolled to further observe the safety and efficacy.
      The DLT(Dose limited toxicity) observation period is set as the first course of treatment(3
      weeks). The end point is that the patient has been taking the drug for 16 cycles or 1 year,
      or the patient dies or develops intolerable toxicity or confirmed disease recurrence or
      distant metastasis or withdrawal of informed consent.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Dose limiting toxicity (DLT)

Secondary Outcome

 AUC(0-t)

Condition

Biliary Tract Cancer

Intervention

ZKAB001 5mg/kg

Study Arms / Comparison Groups

 Combined the therapy using Capecitabine and PD-L1
Description:  PD-L1 antibody ZKAB001 D1 5mg/kg every three weeks,up to 16 cycles or 1 year of treatment or the patient has tumor recurrence or metastasis Capecitabine 1000mg / m2/time, 2 times/d for 2 weeks, followed by 1 week of stopping ,three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

December 1, 2020

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. both men and women, age ≥ 18 years old;

          2. A histopathological or cytological diagnosis of gallbladder cancer and extrahepatic
             cholangiocarcinoma after radical resection

          3. Postoperative pathological stage is T2-4 or N1 R0/R1 resection;

          4. No more than 12 weeks from radical resection;

          5. Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;

          6. Estimated life expectancy >6 months;

          7. Biliary drainage is in good condition, no current infection ;

          8. Have not received radiotherapy, chemotherapy, or immunotherapy for the primary tumor;

          9. The function of important organs meets the following requirements:

        (1) Blood routine test: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L,
        hemoglobin ≥100g/L; (2) Biochemical tests : ALT, AST ≤ 2.5×ULN; ALB≥ 35g/L;total bilirubin
        ≤3×ULN; serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥50 mL/min(Crockcroft-Gault
        formula); 10.Subjects voluntarily joined the study, signed an informed consent form, had
        good compliance, and cooperated with the follow-up.

        Exclusion Criteria:

          1. Local recurrence or distant metastasis (including ascites or malignant pleural
             effusion);

          2. Severe cardiovascular disease, such as New York Heart Association (New York Heart
             Association, NYHA standard) heart failure above grade 2, unstable angina, unstable
             arrhythmia, or color photos of the heart suggest LVEF (left ventricular ejection
             fraction) )<50%;

          3. Known allergy or hypersensitivity to monoclonal antibodies or fluorouracil drugs or
             their analogues;

          4. Subjects with known, active or suspicious autoimmune diseases, who are in a stable
             state and do not require systemic immunosuppressive therapy can be included in the
             group;

          5. Subjects were treated with immunosuppressants or systemic or absorbable topical
             corticosteroids within 2 weeks before the first study to achieve immunosuppressive
             purposes (>10mg/day prednisone or equivalent dose) ;

          6. Suffered from other active malignancies within 5 years before the first administration
             of the study drug. Cured localized tumors, such as skin basal cell carcinoma, skin
             squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ,
             cervical carcinoma in situ, breast carcinoma in situ, etc. can be included in the
             group;

          7. Active viral hepatitis (such as hepatitis B, hepatitis C, unless antiviral treatment
             is given and the HBV or HCV viral load is below the minimum detection limit can be
             considered for inclusion), HIV positive or a known history of acquired
             immunodeficiency syndrome ;

          8. Any active infection that requires systemic anti-infective treatment occurs within 14
             days before the first medication;

          9. Have active tuberculosis in the past 1 year, regardless of treatment;

         10. Live attenuated vaccines have been used within 28 days before screening;

         11. Subjects who have previously received allogeneic bone marrow transplantation or solid
             organ transplantation;

         12. Have received any other experimental drug treatment within 28 days before signing the
             ICF;

         13. People who have difficulty swallowing or have known drug absorption disorders;

         14. Women who are pregnant or breastfeeding;

         15. Subjects of childbearing age who refuse to use effective contraceptive measures;

         16. Situations that other researchers think are not suitable for inclusion. -
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 13761254228, [email protected]



Administrative Informations


NCT ID

NCT04608786

Organization ID

NTL-LEES-2019-01


Responsible Party

Sponsor

Study Sponsor

Lee's Pharmaceutical Limited


Study Sponsor

, , 


Verification Date

October 2020