A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

NCT06778031 | Recruiting Phase 2

• 1 other identifier: SHR-A1811-215
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

This study is an open, multicenter Phase II clinical trial to evaluate the efficacy and safety of the SHR-A1811 combination in HER2 positive patients with locally advanced or metastatic biliary tract cancer.

Conditions

HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) of the SHR-A1811 combination evaluated by investigators

  Screening up to study completion, an average of 3 year.

Secondary Outcomes (5)

• Duration of response (DoR) of the SHR-A1811 combination evaluated by investigators

  Screening up to study completion, an average of 3 year.

• Disease control rate (DCR) of the SHR-A1811 combination evaluated by investigators

  Screening up to study completion, an average of 3 year.

• Progression free survival (PFS) of the SHR-A1811 combination evaluated by investigators

  Screening up to study completion, an average of 3 year.

• Overall survival (OS) of the SHR-A1811 combination evaluated by investigators

  Screening up to study completion, an average of 3 year.

• Adverse events (AEs)

  Screening up to study completion, an average of 3 year.

Study Arms (1)

The SHR-A1811 combination group

EXPERIMENTAL

Drug: SHR-A1811; Drug: SHR-1316; Drug: SHR-8068

Interventions

SHR-A1811 DRUG

SHR-A1811.

The SHR-A1811 combination group

SHR-1316 DRUG

SHR-1316.

The SHR-A1811 combination group

SHR-8068 DRUG

SHR-8068.

The SHR-A1811 combination group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old (including both ends), male or female;
• ECOG-PS score: 0 or 1;
• Expected survival ≥ 12 weeks;
• Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
• Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
• The main organ function is normal, in line with the program requirements;
• Consent to contraception.

You may not qualify if:

• Other active malignancies within 5 years or at the same time;
• Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
• Subjects with biliary obstruction should be excluded;
• There is active autoimmune disease or a history of autoimmune disease that may recur;
• Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
• Severe infection within 4 weeks prior to initiation of study treatment;
• Active hepatitis B virus (HBV) infection;
• Have serious cardiovascular and cerebrovascular diseases.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tingting Lei, BM

CONTACT

+86-18610051325; tingting.lei.tl6@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: February 26, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

CN (2)