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

NCT ID: NCT05417230

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2025-08-31

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.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RC48-ADC plus envafolimab

Group Type: EXPERIMENTAL

RC48-ADC

Intervention Type: DRUG

2.5mg/kg, IV, d1, every 2 weeks;

Envafolimab

Intervention Type: DRUG

200mg, SC, d1, every 2 weeks;

Interventions

RC48-ADC

2.5mg/kg, IV, d1, every 2 weeks;

Intervention Type: DRUG

Envafolimab

200mg, SC, d1, every 2 weeks;

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Liangjun Zhu M.M.

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liangjun Zhu

Role: STUDY_CHAIR

Jiangsu Cancer Institute & Hospital

Central Contacts

Liangjun Zhu

Role: CONTACT

zhulj98@foxmail.com

+8613905199123

Sheng Li

Role: CONTACT

lihsh198@163.com

+8613770768636

Other Identifiers

2022-030

Identifier Type: -

Identifier Source: org_study_id