A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 in Patients with Locally Advanced or Metastatic Solid Tumors.
DISEASE:
Locally Advanced or Metastatic Solid Tumors
SUMMARY:
Although targeted therapy and immunotherapy have revolutionized systemic treatment of various cancers in the past decade, management of advanced and/or metastatic cancers is still a great challenge. For example, many patients with advanced gastrointestinal cancers such as gastric cancer, pancreatic cancer, BTC (including gallbladder cancer and cholangiocarcinoma), or lung cancer still do not significantly benefit from current standard of care. Chemotherapy remains the mainstream treatment for most of these advanced stage cancer patients and their prognosis is still very poor.
Gastric cancer is the fifth most common and the third deadliest cancer worldwide. Esophageal cancer is the 7th most frequently diagnosed cancer and 6th leading cause of cancer-related deaths in 2018. The overall survival of gastroesophageal adenocarcinoma is 20-25%. Five-year survival rate of patients with metastatic gastric or gastroesophageal adenocarcinoma is only 5.3%.
TST001 is an IgG1 monoclonal antibody directed against Claudin 18.2 (CLDN18.2). CLDN18.2 is mostly expressed in gastric cancer and gastroesophageal junction cancers. CLDN18.2 has also been reported in pancreatic, ovarian, biliary and lung cancers, etc. TST001 has been engineered to act against tumor cells which express CLDN18.2. By acting against CLDN18.2, it is expected to kill your cancer cells.
This study will consist of two parts; Part A and Part B. Part A is for subjects with advanced solid tumor cancers, regardless of the CLDN18.2 expression in the tumor. In Part B portion of the trial, only subjects with solid tumors which express CLDN18.2 will be enrolled.
If you would like more information please call PCSRI at 717-334-4033 ext 131, 148, or 149, or email research@pcsri.com.
