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RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

Primary Purpose

Biliary Tract Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
RC48-ADC
Envafolimab
Sponsored by
Jiangsu Cancer Institute & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years;

    • ECOG 0-1;
    • patients diagnosed by pathological or cytological diagnosis of locally advanced or metastatic biliary tract cancer (include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder and ampullary carcinoma);
    • life expectancy of at least 3 months;
    • HER2 IHC 2+ or 3+;
    • At least one measurable objective tumor lesion according to RECIST 1.1;
    • Not received systemic chemotherapy in the past. Patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial.
    • satisfactory main organ function (laboratory test must meet the following criteria): hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, Serum creatinine (CR) ≤1.5 upper normal limitation (UNL), total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), left ventricular ejection fraction (LVEF) ≥ 50%;
    • Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects;

Exclusion Criteria:

  • Previously received drug therapy against PD-1/PD-L1 inhibitor and other Antibody conjugate drug (Such as T-DM1 and DS8201);
  • Allergic to the active ingredients or excipients of the study drug;
  • biliary obstruction were excluded. Unless blockage is treated locally, such as endoscopic stenting, percutaneous hepatic drainage, etc., total bilirubin is reduced below the upper limit of 1.5 UNL;
  • A history of malignancies other than biliary tract malignancies (other than cured carcinoma in situ of the cervix or basal cell carcinoma of the skin and other malignancies cured for 5 years);
  • Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture;
  • Unsuitable for the study or other chemotherapy determined by investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    RC48-ADC plus envafolimab

    Arm Description

    Outcomes

    Primary Outcome Measures

    ORR
    Objective response rate

    Secondary Outcome Measures

    DCR
    Disease Control Rate
    DOR
    Duration of Response
    PFS
    Progression Free Survival
    OS
    Overall Survival
    AEs
    Percentage of participants experiencing grade 3-5 adverse events

    Full Information

    First Posted
    June 9, 2022
    Last Updated
    June 9, 2022
    Sponsor
    Jiangsu Cancer Institute & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05417230
    Brief Title
    RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2
    Official Title
    RC48-ADC in Combination With Envolizumab for the First-line Treatment of Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2: A Prospective, Single-arm Phase II Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Jiangsu Cancer Institute & Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study was a prospective, single-arm phase II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC combined envafolimab in the first-line treatment of locally advanced or metastatic biliary tract cancer with positive HER-2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Tract Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    29 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    RC48-ADC plus envafolimab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    RC48-ADC
    Intervention Description
    2.5mg/kg, IV, d1, every 2 weeks;
    Intervention Type
    Drug
    Intervention Name(s)
    Envafolimab
    Intervention Description
    200mg, SC, d1, every 2 weeks;
    Primary Outcome Measure Information:
    Title
    ORR
    Description
    Objective response rate
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    DCR
    Description
    Disease Control Rate
    Time Frame
    9 months
    Title
    DOR
    Description
    Duration of Response
    Time Frame
    12 months
    Title
    PFS
    Description
    Progression Free Survival
    Time Frame
    6 months
    Title
    OS
    Description
    Overall Survival
    Time Frame
    12 months
    Title
    AEs
    Description
    Percentage of participants experiencing grade 3-5 adverse events
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    ctDNA
    Description
    circulating tumor DNA
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years; ECOG 0-1; patients diagnosed by pathological or cytological diagnosis of locally advanced or metastatic biliary tract cancer (include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder and ampullary carcinoma); life expectancy of at least 3 months; HER2 IHC 2+ or 3+; At least one measurable objective tumor lesion according to RECIST 1.1; Not received systemic chemotherapy in the past. Patients who have completed adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy regimen in this trial 6 months ago can be included in this trial. satisfactory main organ function (laboratory test must meet the following criteria): hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×109/L, platelet count (PLT) ≥80×109/L, Serum creatinine (CR) ≤1.5 upper normal limitation (UNL), total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), left ventricular ejection fraction (LVEF) ≥ 50%; Subjects of childbearing potential must use an appropriate method of contraception during the study period and within 120 days after the end of the study, have a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects; Exclusion Criteria: Previously received drug therapy against PD-1/PD-L1 inhibitor and other Antibody conjugate drug (Such as T-DM1 and DS8201); Allergic to the active ingredients or excipients of the study drug; biliary obstruction were excluded. Unless blockage is treated locally, such as endoscopic stenting, percutaneous hepatic drainage, etc., total bilirubin is reduced below the upper limit of 1.5 UNL; A history of malignancies other than biliary tract malignancies (other than cured carcinoma in situ of the cervix or basal cell carcinoma of the skin and other malignancies cured for 5 years); Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of study treatment; or had a long-term unhealed wound or fracture; Unsuitable for the study or other chemotherapy determined by investigator.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liangjun Zhu
    Phone
    +8613905199123
    Email
    zhulj98@foxmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sheng Li
    Phone
    +8613770768636
    Email
    lihsh198@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liangjun Zhu
    Organizational Affiliation
    Jiangsu Cancer Institute & Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

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