Phase 1b Study of Tolododekin Alfa with Anti-PD-1PD-L1 Antibody for Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating tolododekin alfa also known as ANK-101 combined with an anti-PD-1PD-L1 antibody in adults with advanced or metastatic non-small cell lung cancer NSCLC. The study includes two groups one with participants who have progressed after standard treatments including anti-PD-1PD-L1 antibodies and chemotherapy, and another with participants who have not previously received treatment for their advanced NSCLC. This Phase 1b study aims to assess how this combination affects the cancer and its safety profile. Participants will receive tolododekin alfa as an injection into the tumor every three weeks, combined either with cetrelimab or an FDA-approved anti-PD-1PD-L1 antibody chosen by the investigator. Treatment will be given for up to eight cycles, lasting up to one year. The study is divided into two experimental cohorts based on prior treatment history, with dosing schedules aligned to these cohorts. Throughout the study, participants will undergo regular assessments including imaging to measure tumor response using RECIST v1.1 criteria, laboratory tests, electrocardiograms, and monitoring for side effects. Researchers will track response rates, duration of response, disease control, progression-free survival, overall survival, and detailed pharmacokinetic measures of tolododekin alfa. The study participation may last at least six months with ongoing safety and efficacy monitoring.

A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer