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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
SHR-A1904 for injection, different doses.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR) assessed by investigator.
Phase IIa.
Time frame: Until progression, assessed up to approximately 1 year.
Disease control rate (DCR) assessed by investigator.
Phase IIa/IIb.
Time frame: Approximately 1 year.
Duration of objective tumor response (DoR) assessed by investigator.
Phase IIa/IIb.
Time frame: Approximately 1 year.
Time to response (TTR) assessed by investigator.
Phase IIa/IIb.
Time frame: Approximately 1 year.
Progression-free survival (PFS) assessed by investigator.
Phase IIa/IIb.
Time frame: Approximately 1 year.
Overall survival (OS).
Phase IIa/IIb.
Time frame: Approximately 2 years.
Adverse events (AEs).
Phase IIa/IIb.
Time frame: Until study completion, assessed up to approximately 1 year.
Serious adverse events (SAEs).
Phase IIa/IIb.
Time frame: Until study completion, assessed up to approximately 1 year.
Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA).
Phase IIa/IIb.
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Time frame: Approximately 6 months.
Immunogenicity indicators of SHR-A1904: neutralizing antibody (NAb).
Phase IIa/IIb.
Time frame: Approximately 6 months.