Biliary Tract Neoplasms
Conditions
Interventions
Experimental group:Drug: TST001
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with unresectable advanced or metastatic cholangiocarcinoma confirmed by histology or cytology; 2. Failure to receive at least first-line treatment in the past (disease progression or intolerance); progression during neoadjuvant chemotherapy or adjuvant chemotherapy or within 6 months after completion can be considered a failure of first-line treatment; 3. The tumor tissue is positive for CLDN18.2; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. The expected survival period is at least 3 months; 6. According to the evaluation criteria for solid tumors (RECIST v1.1), the subject must have at least one measurable lesion; 7. Have sufficient organ and hematopoietic function.
Exclusion criteria
Exclusion criteria: 1. Complicated with other malignant tumors within 5 years before the first administration, except for adequately treated cervical carcinoma in situ, local squamous cell carcinoma of the skin, basal cell carcinoma, papillary thyroid carcinoma, breast ductal carcinoma in situ or <=T1N0M0 urothelial carcinoma, prostate cancer that does not require treatment (resection or unresection), etc., or the investigator believes that recurrence is unlikely or will not metastasize or cause death of the subject in this study ; 2. Untreated known central nervous system (CNS) metastases, or symptomatic CNS metastases; 3. The previous treatment meets one of the following conditions: major surgery within 4 weeks before the first dose; the interval between the first dose of extensive radiation therapy is <= 28 days, or the interval between the first dose of palliative local radiotherapy is <= 2 weeks; Received chemoembolization or radiofrequency ablation within 4 weeks before the first dose; Previous chemotherapy, anti-tumor biological therapy (tumor vaccines, cytokines, etc.), anti-tumor traditional Chinese medicine or targeted therapy interval <= 28 days or <= 5 half-lives (whichever is shorter) from the first administration of this study; 4. Subjects who have received anti-CLDN18.2 treatment (including CLDN18.2 monoclonal antibody, double antibody, antibody conjugated drug, cell therapy, etc.); 5. Severe cardiovascular and cerebrovascular diseases, including cerebrovascular accident, transient ischemic attack, myocardial infarction or unstable angina pectoris, occurred within 6 months before the first administration, New York Heart Association Class III or IV heart failure or uncontrolled arrhythmia; 6. It is known that the subjects have had severe allergic reactions to macromolecular protein preparations/monoclonal antibodies or known to any component of the test drug; 7. Subjects who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Disease Response (DOR);Time to Response (TTR);Progression Free Survival (PFS);Overall Survival (OS);Occurrence, Severity and Incidence of Various Adverse Events (AE); | — |
Countries
China
Contacts
Public ContactFan Jia
Outcome results
None listed