Recruiting NCT07450976
A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1904 for Injection.
- Who it may be relevant to
- Registry conditions: Biliary Tract Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug SHR-A1904 for Injection
SHR-A1904 for injection, different doses.
Primary outcome measures
- Objective response rate (ORR) assessed by investigator. [Time frame: Until progression, assessed up to approximately 1 year.]
Secondary outcome measures (9)
- Disease control rate (DCR) assessed by investigator. [Time frame: Approximately 1 year.]
- Duration of objective tumor response (DoR) assessed by investigator. [Time frame: Approximately 1 year.]
- Time to response (TTR) assessed by investigator. [Time frame: Approximately 1 year.]
- Progression-free survival (PFS) assessed by investigator. [Time frame: Approximately 1 year.]
- Overall survival (OS). [Time frame: Approximately 2 years.]
- Adverse events (AEs). [Time frame: Until study completion, assessed up to approximately 1 year.]
- Serious adverse events (SAEs). [Time frame: Until study completion, assessed up to approximately 1 year.]
- Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA). [Time frame: Approximately 6 months.]
- Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb). [Time frame: Approximately 6 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
- Zhongshan Hospital, Fudan University — Shanghai
Identifiers
NCT: NCT07450976 · SHR-A1904-201