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

Biliary Tract Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05417230
• Other study ID #: 2022-030
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2022
• Est. completion date: August 2025

Study information

• Verified date: June 2022
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Liangjun Zhu
• Phone: +8613905199123
• Email: zhulj98[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 29
• Est. completion date: August 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• RC48-ADC
2.5mg/kg, IV, d1, every 2 weeks;
• Envafolimab
200mg, SC, d1, every 2 weeks;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ctDNA	circulating tumor DNA	12 months
Primary	ORR	Objective response rate	6 months
Secondary	DCR	Disease Control Rate	9 months
Secondary	DOR	Duration of Response	12 months
Secondary	PFS	Progression Free Survival	6 months
Secondary	OS	Overall Survival	12 months
Secondary	AEs	Percentage of participants experiencing grade 3-5 adverse events	12 months