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NCT05907980PHASE1Recruiting

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

Chugai Pharmaceutical

Start Date

5/24/2023

Completion Date

10/31/2027

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 Criteria

Age Range: 18 years to No maximum

* Age \>= 18 years at time of signing informed consent form (ICF) * Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1 * Adequate hematologic and end-organ function * Life expectancy \>= 12 weeks * Patients with histologic documentation of locally advanced, or metastatic solid tumor * \[Dose-escalation Parts and Biopsy Parts\]Refractory or resistant to standard therapies or standard therapies are not available * \[Dose-escalation Parts and Expansion Part\] Patients with confirmed availability of fresh tumor or representative tumor specimens * \[Biopsy Parts\] Patients with accessible lesion(s) * \[Expansion Parts\] Patients with ICI (immune checkpoint inhibitor)-refractory 2L-3L NSCLC (non-small-cell lung cancer) and 3L+ CRC (colorectal cancer) Exclusion Criteria: * 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

Interventions

DRUG

ROSE12

DRUG

Atezolizumab

DRUG

Pembrolizumab

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Conditions

Solid Tumor

Locations

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania 19104

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

NEXT Oncology

Fairfax, Virginia 22031

United States

Aichi Cancer Center

Nagoya, Aichi-ken 464-8681

Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba 277-8577

Japan

Kanagawa Cancer Center

Yokohama, Kanagawa 241-8515

Japan

Kansai Medical University Hospital

Hirakata-shi, Osaka 573-1191

Japan

Osaka International Cancer Institute

Osaka, Osaka 541-8567

Japan

Kindai University Hospital

Sakai-shi, Osaka 590-0197

Japan

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka 411-8777

Japan

National Cancer Center Hospital

Chuo-ku, Tokyo 104-0045

Japan

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo 135-8550

Japan