Phase IaIb Study of ROSE12 with or without Atezolizumab or Pembrolizumab in Patients with Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a Phase IaIb open-label study to evaluate the safety and pharmacokinetics of ROSE12 alone and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study includes three parts dose escalation, biopsy for biomarker evaluation, and expansion in selected tumor types. The goal is to find the maximum tolerated dose and recommended dose, as well as to assess safety and preliminary anti-tumor activity. Participants will receive ROSE12 as an intravenous infusion at increasing doses, either alone or combined with atezolizumab or pembrolizumab, also given by intravenous infusion. Serial biopsies will be performed in some parts to study biomarkers. The study consists of multiple parts including dose-escalation phases, biopsy phases, and expansion phases where patients receive recommended doses of the drug combinations. During the study, participants will have safety and tolerability monitored from screening through treatment and follow-up, for up to approximately 43 months. Researchers will measure pharmacokinetics by monitoring serum concentrations of the drugs and assess preliminary anti-tumor effects. Biomarker evaluations and immunogenicity assessments will also be conducted. Participants will have regular visits for infusions, biopsies, and safety assessments throughout the study period.

A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors