RecruitingPhase 1NCT05907980

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


Sponsor

Chugai Pharmaceutical

Enrollment

209 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Atezolizumab and a drug called ROSE12 for people with solid tumor. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGROSE12

ROSE12 as a IV infusion

DRUGAtezolizumab

Atezolizumab as a IV infusion

DRUGPembrolizumab

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

View Full Details on ClinicalTrials.gov

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NCT05907980


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