Safety and Efficacy of RX-af01 Combined With PD-1 Antibody
Status:
Recruiting
Trial end date:
2023-09-20
Target enrollment:
Participant gender:
Summary
This phase I trial evaluates the effects of RX-af01 in combination with toripalimab (PD-1
antibody), in treating patients with refractory advanced solid tumors, including melanoma,
nasopharyngeal squamous carcinoma, esophageal squamous cell carcinoma, gastric
adenocarcinoma, renal cell carcinoma, et al. RX-af01 is a kind of anti-tumor intestinal
bacteria developed by our research group. Its main components are symbiotic bacteria from
human intestine - Alisipes finegoldii (A. finegoldii.), which is a Gram negative anaerobic
bacteria. Our previous research shows that A finegoldii. can significantly enhance the
anti-tumor activity of PD-1 antibody in multiple mouse tumor models. Mechanism research shows
that A finegoldii. can increase the infiltration of CD4 and CD8 positive immune cells in the
tumor microenvironment, and enhances the anti-tumor activity of immune cells. The primary aim
of this study is to explore the efficacy and safety of RX-af01 combined with PD-1 antibody in
refractory advanced solid tumors.