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

NCT05417230 | Unknown Phase 2

• 1 other identifier: 2022-030
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  6 months

Secondary Outcomes (5)

• DCR

  9 months

• DOR

  12 months

• PFS

  6 months

• OS

  12 months

• AEs

  12 months

Other Outcomes (1)

• ctDNA

  12 months

Study Arms (1)

RC48-ADC plus envafolimab

EXPERIMENTAL

Drug: RC48-ADC; Drug: Envafolimab

Interventions

RC48-ADC DRUG

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

RC48-ADC plus envafolimab

Envafolimab DRUG

200mg, SC, d1, every 2 weeks;

RC48-ADC plus envafolimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Cancer Institute & Hospital: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

envafolimab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Liangjun Zhu

  Jiangsu Cancer Institute & Hospital

  STUDY CHAIR

Central Study Contacts

Liangjun Zhu

CONTACT

+8613905199123; zhulj98@foxmail.com

Sheng Li

CONTACT

+8613770768636; lihsh198@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share