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RECRUITING
NCT05907980
PHASE1

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

Sponsor: Chugai Pharmaceutical

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

219

Start Date

2023-05-24

Completion Date

2026-12-31

Last Updated

2025-03-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

ROSE12

ROSE12 as a IV infusion

DRUG

Atezolizumab

Atezolizumab as a IV infusion

Locations (4)

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan