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New treatment option for Biliary Tract Cancer
Official title A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07450976
What this study is testing
What is SHR-A1904 for Injection?
SHR-A1904 for Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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;
You likely can't join if
- Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before...
- Other active malignancies within 5 years or at the same time;
- people 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;
See the full eligibility 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;
- people who failed or intolerance after systemic chemotherapies;
- According to the RECIST v1.1 standard, the people had at least one measurable lesion;
- The main organ function is normal, in line with the program requirements;
- Consent to contraception.
- 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;
- people 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.