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

NCT05907980 | Recruiting Phase 1 FDA Drug

• 1 other identifier: RSE101CT
• Study Type: interventional
• Target: 209
• Locations: 2 countries
• Sites: 14

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (6)

• The maximum tolerated dose (MTD) and the recommended dose (RD) of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A and C)

  Incidence and nature of dose-limiting toxicities (DLTs)

  From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)

• Safety (All Parts) and tolerability (Part A, B, C and D) of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (Adverse Events)

  Incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  From screening until study completion, treatment discontinuation or post-treatment follow up, assessed up to the end of the study (approximate 43 months)

• The maximum serum concentration (Cmax) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  The maximum serum concentration (Cmax) of ROSE12

  From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• The minimum serum concentration (Cmin) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  The minimum serum concentration (Cmin) of ROSE12

  From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• The area under the concentration time-curve (AUC) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  The area under the concentration time-curve (AUC) of ROSE12

  From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab or pembrolizumab (Part E and F)

  Objective response rate (ORR), defined as the proportion of patients with an objective response (complete response \[CR\] or partial response \[PR\]) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

Secondary Outcomes (13)

• Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A, B, C and D)

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)

  From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

• The maximum serum concentration (Cmax) of atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E)

  From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

Study Arms (6)

Part A: Dose-escalation part of Phase Ia

EXPERIMENTAL

Patients will receive ROSE12 as a IV infusion at escalated doses.

Drug: ROSE12

Part B: Biopsy part of Phase Ia

EXPERIMENTAL

Serial biopsy will be conducted with patients who will receive ROSE12 as a IV infusion at escalated doses.

Drug: ROSE12

Part C: Dose-escalation part of Phase Ib

EXPERIMENTAL

Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

Drug: ROSE12; Drug: Atezolizumab

Part D: Biopsy part of Phase Ib

EXPERIMENTAL

Serial biopsy will be conducted with patients who will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

Drug: ROSE12; Drug: Atezolizumab

Part E: Expansion part of Phase Ib in patients with selected solid tumors

EXPERIMENTAL

Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.

Drug: ROSE12; Drug: Atezolizumab

Part F: Expansion part of Phase Ib in patients with selected solid tumors

EXPERIMENTAL

Patients will receive ROSE12 and pembrolizumab as a IV infusion at the recommended dose.

Drug: ROSE12; Drug: Pembrolizumab

Interventions

ROSE12 DRUG

ROSE12 as a IV infusion

Part A: Dose-escalation part of Phase Ia; Part B: Biopsy part of Phase Ia; Part C: Dose-escalation part of Phase Ib; Part D: Biopsy part of Phase Ib; Part E: Expansion part of Phase Ib in patients with selected solid tumors; Part F: Expansion part of Phase Ib in patients with selected solid tumors

Atezolizumab DRUG

Atezolizumab as a IV infusion

Part C: Dose-escalation part of Phase Ib; Part D: Biopsy part of Phase Ib; Part E: Expansion part of Phase Ib in patients with selected solid tumors

Pembrolizumab DRUG

Pembrolizumab as a IV infusion

Part F: Expansion part of Phase Ib in patients with selected solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (14)

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

RECRUITING

Kindai University Hospital

Sakai-shi, Osaka, 590-0197, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, 411-8777, Japan

RECRUITING

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

RECRUITING

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, 135-8550, Japan

RECRUITING

Related Publications (1)

• Hayashi H, Tatsumi K, Katada H, Matsuda Y, Tsunenari T, Honda M, Nemoto T, Shimizu S, Miura-Okuda M, Ikuta Y, Ito A, Ogami C, Kato C, Kamimura M, Kibayashi T, Kubo C, Komatsu S, Komori Y, Shinozuka J, Susumu H, Tanno H, Tomii Y, Nakagawa K, Nagano H, Nanami M, Nishito Y, Fujisawa N, Matsushita T, Michisaka S, Yamazaki M, Yoshimoto M, Wakatsuki H, Wakabayashi T, Wada NA, Ueda O, Konishi H, Kashima K, Tanaka H, Endo M, Kitazawa T, Sakaguchi S, Kamata-Sakurai M, Igawa T. ROSE12, a novel anti-CTLA-4 FcgammaRs binding-enhanced antibody activated by extracellular adenosine triphosphate, shows tumor-selective regulatory T-cell depletion and antitumor efficacy without systemic immune activation. J Immunother Cancer. 2026 Jan 9;14(1):e013397. doi: 10.1136/jitc-2025-013397.

  PMID: 41513409 DERIVED

MeSH Terms

Interventions

atezolizumab; pembrolizumab

Study Officials

• Sponsor Chugai Pharmaceutical Co.Ltd

  clinical-trials@chugai-pharm.co.jp

  STUDY DIRECTOR

Central Study Contacts

Clinical trials information

CONTACT

only use Email; clinical-trials@chugai-pharm.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: June 18, 2023
• Study Start: May 24, 2023
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

JP (9); US (5)