Qilu Pharma Initiates Phase II Clinical Trial of QLS31905 for CLDN18.2-Positive Advanced Biliary Tract Cancer

Drug Clinical Trial Registration Information Shows That Qilu Pharmaceutical Co., Ltd.'s Phase II Clinical Study Evaluating the Efficacy and Safety of Injectable QLS31905 in Combination with Chemotherapy ± QL2107 for the Treatment of CLDN18.2-positive Advanced Biliary Tract Cancer Patients Has Been Initiated. The clinical trial registration number is CTR20253464, and the initial information disclosure date was August 27, 2025.

The investigational drug includes multiple dosage forms, such as injections and tablets. The usage of injectable QLS31905 is 800 μg/kg administered via intravenous infusion, once every 3 weeks; the usage of injectable QL2107 is 200 mg administered via intravenous infusion, once every 3 weeks, etc. The purpose of this trial is to evaluate the efficacy of QLS31905 in combination therapy for CLDN18.2-positive advanced biliary tract cancer.

QLS31905 for Injection is a biologic product, indicated for advanced biliary tract cancer. Advanced biliary tract cancer refers to the late stage of malignant tumors occurring in the bile duct area, with symptoms such as jaundice and abdominal pain. Diagnosis relies on imaging and pathological examination, with limited treatment options and poor prognosis.

The primary endpoint of this trial includes the Objective Response Rate (ORR) evaluated by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1); secondary endpoints include Progression-Free Survival (PFS), Duration of Response (DoR), Disease Control Rate (DCR) assessed by the investigator based on RECIST v1.1, safety indicators such as the incidence and severity of Adverse Events (AE)/Serious Adverse Events (SAE), and the PK characteristics of QLS31905.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 120 participants.

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Editor: Xiaolang Express