Biliary Tract Cancer
Conditions
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.
Interventions
SHR-A1904 for injection, different doses.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) assessed by investigator. | Until progression, assessed up to approximately 1 year. | Phase IIa. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) assessed by investigator. | Approximately 1 year. | Phase IIa/IIb. |
| Duration of objective tumor response (DoR) assessed by investigator. | Approximately 1 year. | Phase IIa/IIb. |
| Time to response (TTR) assessed by investigator. | Approximately 1 year. | Phase IIa/IIb. |
| Progression-free survival (PFS) assessed by investigator. | Approximately 1 year. | Phase IIa/IIb. |
| Overall survival (OS). | Approximately 2 years. | Phase IIa/IIb. |
| Adverse events (AEs). | Until study completion, assessed up to approximately 1 year. | Phase IIa/IIb. |
| Serious adverse events (SAEs). | Until study completion, assessed up to approximately 1 year. | Phase IIa/IIb. |
| Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA). | Approximately 6 months. | Phase IIa/IIb. |
| Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb). | Approximately 6 months. | Phase IIa/IIb. |
Countries
China
Contacts
CONTACTHaoyang Xin
Outcome results
None listed