Qilu Pharmaceutical Initiates Ib/II Clinical Trial of QLC12102 (CEND-1) for Metastatic Pancreatic Cancer

Recently, Qilu Pharmaceutical announced that a Phase Ib/II clinical trial for QLC12102 (CEND-1 for injection) has been initiated at the Chinese PLA General Hospital. The study is being conducted in patients with advanced metastatic pancreatic cancer to evaluate the safety, pharmacokinetics, and preliminary efficacy of QLC12102 in combination with chemotherapy. Professor Xu Jianming from the Chinese PLA General Hospital serves as the lead principal investigator, with 15 research centers across China participating.

Pancreatic cancer is currently recognized as the most highly malignant tumor and is referred to by the medical community as one of the "stubborn fortresses of the 21st century." The incidence of pancreatic cancer continues to show a sustained upward trend globally. QLC12102 is a tumor-penetrating peptide (also known as iRGD). QLC12102 initially binds to alpha-v integrin (Integrin alpha-V), and following enzymatic cleavage, interacts with neuropilin-1 to increase tumor tissue permeability. When administered in combination with standard chemotherapeutic agents and other drugs, QLC12102 enhances the delivery efficiency of these agents into tumors, improves drug specificity and sensitivity, strengthens anti-tumor therapeutic efficacy, and holds promise for overcoming the therapeutic bottleneck associated with the "King of Cancers."

A Phase I clinical study conducted in patients with advanced metastatic pancreatic cancer demonstrated that QLC12102 combined with nab-paclitaxel (albumin-bound paclitaxel) and gemcitabine achieved an ORR of 58.8% and an mPFS of 9.7 months, with a favorable overall safety profile. These findings suggest that QLC12102 in combination with chemotherapy holds significant potential for advanced metastatic pancreatic ductal adenocarcinoma.

In February this year, Qilu Pharmaceutical and Cend Therapeutics signed a collaboration and license agreement, securing the rights to develop and commercialize CEND-1 for injection in the Greater China region. Qilu Pharmaceutical is fully advancing the clinical development of this project in China, with the expectation that this novel drug will bring a significant breakthrough to pancreatic cancer treatment and benefit patients as soon as possible.

Responsible Editor: Liuli

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