This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
QLS31905 for Injection
Gemcitabine Hydrochloride for Injection
Cisplatin for Injection
ORR (Objective Response Rate)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1
Time frame: Approximately 24 months
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QL2107 Injection
Oxaliplatin Injection
Capecitabine Tablets