A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

March 30, 2026 updated by: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

A Phase IIa/IIb Clinical Study of SHR-A1904 in Patients With Previous Systemic Treatment Failure, Positive CLDN18.2 Expression of Locally Advanced Unresectable or Recurrent Metastatic Biliary Tract Cancer

This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Principal Investigator:
          • Hong Zhao
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
        • Principal Investigator:
          • Qiang Gao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years old (including both ends), male or female;
  2. ECOG-PS score: 0 or 1;
  3. Expected survival ≥ 12 weeks;
  4. Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
  5. CLDN18.2 positive expression;
  6. Subjects who failed or intolerance after systemic chemotherapies;
  7. According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
  8. The main organ function is normal, in line with the program requirements;
  9. Consent to contraception.

Exclusion Criteria:

  1. Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration;
  2. Other active malignancies within 5 years or at the same time;
  3. Subjects with a history or evidence of brain metastasis or meningeal metastasis;
  4. With acute or chronic uncontrolled pancreatitis or Child-Pugh liver function grade C;
  5. Severe trauma or major surgery was performed within 4 weeks before the first administration;
  6. To study the severe heart disease within 6 months before the first administration;
  7. Patients with clinical symptoms and uncontrolled moderate and above pleural effusion, ascites or pericardial effusion, requiring therapeutic puncture drainage;
  8. Severe infection symptoms occurred within 2 weeks before the first administration;
  9. Known hereditary or acquired bleeding and thrombotic tendency;
  10. Congenital or acquired immune defects;
  11. The subjects had severe and uncontrollable concomitant diseases;
  12. Cerebral infarction, pulmonary embolism or deep vein thrombosis occurred within 6 months before the first administration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1904 Cohort A Group
SHR-A1904 for injection, low dose.
Drug: SHR-A1904 for Injection
SHR-A1904 for injection, different doses.
Experimental: SHR-A1904 Cohort B Group
SHR-A1904 for injection, high dose.
Drug: SHR-A1904 for Injection
SHR-A1904 for injection, different doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) assessed by investigator.
Time Frame: Until progression, assessed up to approximately 1 year.
Phase IIa.
Until progression, assessed up to approximately 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR) assessed by investigator.
Time Frame: Approximately 1 year.
Phase IIa/IIb.
Approximately 1 year.
Duration of objective tumor response (DoR) assessed by investigator.
Time Frame: Approximately 1 year.
Phase IIa/IIb.
Approximately 1 year.
Time to response (TTR) assessed by investigator.
Time Frame: Approximately 1 year.
Phase IIa/IIb.
Approximately 1 year.
Progression-free survival (PFS) assessed by investigator.
Time Frame: Approximately 1 year.
Phase IIa/IIb.
Approximately 1 year.
Overall survival (OS).
Time Frame: Approximately 2 years.
Phase IIa/IIb.
Approximately 2 years.
Adverse events (AEs).
Time Frame: Until study completion, assessed up to approximately 1 year.
Phase IIa/IIb.
Until study completion, assessed up to approximately 1 year.
Serious adverse events (SAEs).
Time Frame: Until study completion, assessed up to approximately 1 year.
Phase IIa/IIb.
Until study completion, assessed up to approximately 1 year.
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA).
Time Frame: Approximately 6 months.
Phase IIa/IIb.
Approximately 6 months.
Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb).
Time Frame: Approximately 6 months.
Phase IIa/IIb.
Approximately 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1904-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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