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

Phase 2

Not yet recruiting

• Conditions: Biliary Tract Cancer
• Interventions: Drug: RC48-ADC; Drug: Envafolimab

• Registration Number: NCT05417230
• Lead Sponsor: Jiangsu Cancer Institute & Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14
• Study Start: 2022-08
• Primary Completion: 2024-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RC48-ADC plus envafolimab	RC48-ADC	-
RC48-ADC plus envafolimab	Envafolimab	-

Primary Outcome Measures

Name	Time	Method
ORR	6 months	Objective response rate

Secondary Outcome Measures

Name	Time	Method
OS	12 months	Overall Survival
PFS	6 months	Progression Free Survival
AEs	12 months	Percentage of participants experiencing grade 3-5 adverse events
DCR	9 months	Disease Control Rate
DOR	12 months	Duration of Response