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
About this trial
This is an interventional treatment trial for Biliary Tract Cancer
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.
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
NCT ID
NCT05417230
First Posted
June 9, 2022
Last Updated
June 9, 2022
Sponsor
Jiangsu Cancer Institute & Hospital
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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