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

NCT07450976 | Recruiting Phase 2

• 1 other identifier: SHR-A1904-201
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed by investigator.

  Phase IIa.

  Until progression, assessed up to approximately 1 year.

Secondary Outcomes (9)

• Disease control rate (DCR) assessed by investigator.

  Approximately 1 year.

• Duration of objective tumor response (DoR) assessed by investigator.

  Approximately 1 year.

• Time to response (TTR) assessed by investigator.

  Approximately 1 year.

• Progression-free survival (PFS) assessed by investigator.

  Approximately 1 year.

• Overall survival (OS).

  Approximately 2 years.

Study Arms (2)

SHR-A1904 Cohort A Group

EXPERIMENTAL

SHR-A1904 for injection, low dose.

Drug: SHR-A1904 for Injection

SHR-A1904 Cohort B Group

EXPERIMENTAL

SHR-A1904 for injection, high dose.

Drug: SHR-A1904 for Injection

Interventions

SHR-A1904 for Injection DRUG

SHR-A1904 for injection, different doses.

SHR-A1904 Cohort A Group; SHR-A1904 Cohort B 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;
• CLDN18.2 positive expression;
• Subjects who failed or intolerance after systemic chemotherapies;
• 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:

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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Haoyang Xin

CONTACT

+86-0518-82342973; haoyang.xin.hx5@hengrui.com

Study Design

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

Model Details: The clinical trial is structured to proceed in two phases. Phase IIa is a randomized, open-label trial for efficacy exploration. Participants will be randomized in a 1:1 ratio into Cohort A or Cohort B to receive different doses of SHR-A1904. Phase IIb is a single-arm group for efficacy validation, the dosage of SHR-A1904 will be determined based on the efficacy and safety results from Phase IIa.

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 5, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (2)