NCT05907980

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

A Phase Ia/Ib Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination With Other Anti-tumor Agents in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 219 (estimated)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ROSE12	ROSE12 as a IV infusion
DRUG	Atezolizumab	Atezolizumab as a IV infusion

Timeline

• Start date: 2023-05-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-06-18
• Last updated: 2025-03-06

Locations

4 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study