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

Recruiting now · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT05907980

Run by

Chugai Pharmaceutical

People needed

209

Starts

2023-05-24

Expected to finish

2027-10-31

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Clinically significant cardiovascular or liver disease
• Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
• Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
• All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
• Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Active or history of clinically significant autoimmune disease
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• [Expansion Part]
• Prior treatment with investigational product which has MoA of Treg depletion
• Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1

Where it is running

• University of Pennsylvania Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)
• Aichi Cancer Center — Nagoya, Aichi-ken, Japan (enrolling)
• National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (enrolling)
• Kanagawa Cancer Center — Yokohama, Kanagawa, Japan (enrolling)
• Kansai Medical University Hospital — Hirakata-shi, Osaka, Japan (enrolling)
• Osaka International Cancer Institute — Osaka, Osaka, Japan (enrolling)
• Kindai University Hospital — Sakai-shi, Osaka, Japan (enrolling)
• Shizuoka Cancer Center — Nagaizumi-chō, Shizuoka, Japan (enrolling)
• National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (enrolling)
• The Cancer Institute Hospital of JFCR — Koto-Ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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