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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

209

Start Date

2023-05-24

Completion Date

2027-10-31

Last Updated

2026-07-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

ROSE12

ROSE12 as a IV infusion

DRUG

Atezolizumab

Atezolizumab as a IV infusion

DRUG

Pembrolizumab

Pembrolizumab as a IV infusion

Locations (14)

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Kindai University Hospital

Sakai-shi, Osaka, Japan

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, Japan