Phase 1 Study of NM1F Alone and With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating NM1F, an investigational drug, alone and combined with pembrolizumab Keytruda in people with locally advanced or metastatic solid tumors who have limited treatment options. This Phase 1 study aims to assess the safety, tolerability, how the body processes NM1F, and early signs of anti-tumor activity. The trial is open-label and involves multiple centers. The study has two parts first, NM1F is given alone in a dose escalation phase Phase 1a, then NM1F is given with a fixed dose of pembrolizumab in a second dose escalation phase Phase 1b. Each participant undergoes a screening period up to 28 days, followed by a treatment period lasting up to one year for Phase 1a or up to two years for Phase 1b, or until treatment stops. After treatment, participants enter a follow-up period for further monitoring. Participants will have medical evaluations including scans to measure tumor response, safety assessments, and blood tests to study drug levels and immune response. The main outcomes include assessing dose-limiting toxicities during the first 21 days, frequency and severity of side effects, and determining the best dose over about three years. Researchers will also measure tumor response rates, duration of response, disease control, progression-free survival, and overall survival. The total study duration can be up to several years including follow-up.

A First-in-human, Phase I, Open-label, Multicenter Study of NM1F(Anti-PVRIG) in Patients With Advanced Solid Tumors