AB801 + Chemotherapy + Immunotherapy for Pancreatic Cancer

This trial tests the safety and effectiveness of a new drug, AB801, combined with chemotherapy and immunotherapy for certain types of pancreatic and bile duct cancers. AB801 helps the body's immune system recognize and attack cancer cells by blocking a protein called AXL, which promotes tumor growth and spread. The trial seeks individuals with pancreatic or bile duct cancers that have spread to nearby tissues or other parts of the body and have not been previously treated. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

The trial requires that you stop taking immunosuppressive medications like corticosteroids at doses greater than 10 mg/day at least 2 weeks before starting the study treatment. Other medications that can prolong the QTc interval should be avoided if possible. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Research has shown that AB801 is being tested with chemotherapy and immunotherapy to assess its safety for humans. The primary focus is on patient tolerance, and researchers continue to gather safety information.

For the combination of AB801 with gemcitabine, cisplatin, and durvalumab, some safety data already exist for the chemotherapy and immunotherapy components. Studies have found that durvalumab, when combined with gemcitabine and cisplatin, is generally well-tolerated by patients with advanced biliary tract cancers. Real-world evidence suggests this combination can extend patient survival and has manageable side effects.

Regarding the combination of AB801, zimberelimab, and FOLFIRINOX (a mix of four chemotherapy drugs), previous research indicates that zimberelimab is generally safe and well-tolerated. FOLFIRINOX is commonly used to treat pancreatic cancer; despite its significant side effects, it remains widely used due to its effectiveness.

Researchers are excited about these treatments because they combine innovative therapies with existing chemotherapy options to tackle pancreatic cancer more effectively. Unlike the standard of care, which typically includes chemotherapy regimens like FOLFIRINOX or gemcitabine with nab-paclitaxel, the investigational treatments incorporate AB801, a novel agent, and immunotherapies such as durvalumab and zimberelimab. These immunotherapies work by enhancing the body's immune response against cancer cells, potentially providing a more targeted attack on the tumor. Additionally, combining these drugs with traditional chemotherapy aims to improve treatment efficacy and patient outcomes by leveraging multiple mechanisms of action.

This trial will evaluate two different treatment combinations for pancreatic cancer. In Cohort I, participants will receive AB801, gemcitabine, cisplatin, and durvalumab. Research has shown that adding durvalumab to chemotherapy drugs like gemcitabine and cisplatin can extend life expectancy in people with advanced biliary tract cancers more than chemotherapy alone.