Qilu Pharmaceutical Doses First Patient in Global Pivotal Phase III Trial of QLS31905, the World’s First Claudin18.2/CD3 Bispecific Antibody for First-Line Treatment of Advanced Pancreatic Cancer

Sep 12, 2025 09:38 CST Updated 09:38

Qilu Pharmaceutical

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On September 8, Qilu Pharmaceutical's QLS31905, a self-developed Claudin18.2/CD3 bispecific antibody innovative drug for first-line treatment of advanced pancreatic cancer, has completed the enrollment of its first subject in the pivotal Phase III clinical trial.

This study is a multi-center, double-blind, placebo-controlled, Phase III randomized clinical trial aimed at evaluating the efficacy and safety of QLS31905 in combination with nab-paclitaxel and gemcitabine chemotherapy as a first-line treatment in Claudin18.2-positive patients with advanced pancreatic cancer. Professor Lin Shen from Peking University Cancer Hospital and Professor Jihui Hao from Tianjin Medical University Cancer Institute and Hospital are the principal investigators. This study represents the world's first Claudin18.2/CD3 bispecific antibody therapy to enter Phase III clinical trials.

Pancreatic cancer has a poor prognosis, with a 5-year survival rate of 7.2%, representing a significant unmet clinical need. Currently, chemotherapy remains the first-line standard treatment for patients with advanced pancreatic cancer, but its overall efficacy is limited, with an ORR of approximately 20% and a median OS of less than one year. To date, no first-line immunotherapy for pancreatic cancer patients has been approved globally.

QLS31905 is a bispecific T-cell engager targeting Claudin18.2, capable of binding to Claudin18.2 on the surface of tumor cells and CD3 on the surface of T cells. By recruiting and activating T cells near tumor cells, itTumor cells are continuously lysed and killed.

Previously, the preliminary and updated results of the Phase I clinical study of QLS31905 were presented in poster form at the 2023 ESMO Immuno-Oncology Congress and the 2025 ASCO Annual Meeting, respectively. QLS31905 demonstrated good safety and tolerability and showed promising efficacy signals in patients with advanced gastrointestinal tumors positive for Claudin18.2. The potential breakthrough clinical value of the QLS31905 combination regimen is expected to fill the immunotherapy gap for patients with pancreatic cancer.

The initiation of the Phase III clinical trial will further validate the efficacy and safety of QLS31905 in combination with chemotherapy in patients with Claudin18.2-positive advanced pancreatic cancer, and is expected to become a new first-line immunotherapy option for patients with Claudin18.2-positive pancreatic cancer.

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