Phase 1 Study of PRTH-101 Alone or With Pembrolizumab for Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of PRTH-101, alone or combined with pembrolizumab, in adults with advanced or metastatic solid tumors that are difficult to treat. PRTH-101 is a specialized antibody designed to block DDR1, a protein on tumor cells that creates a barrier preventing immune cells from attacking the tumor. This study aims to find safe doses and observe anti-tumor activity of PRTH-101 both alone and with pembrolizumab. Participants will receive either PRTH-101 alone or in combination with pembrolizumab in an open-label setting, meaning both the researchers and participants know the treatment given. The study includes dose escalation and expansion phases to determine the best dose and assess the effects. Treatment schedules and doses will be monitored over time to evaluate safety and how the drugs behave in the body. During the trial, participants will undergo regular assessments including safety monitoring for adverse events, pharmacokinetic testing to measure drug levels, and evaluations of tumor response. Biopsies of tumors and skin will be performed before and after treatment to study drug effects. The study will last up to four years, with ongoing monitoring of side effects, immune response, and anti-tumor activity throughout this period.

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies