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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose-escalation part of Phase Ia | Experimental | Patients will receive ROSE12 as a IV infusion at escalated doses. |
|
| 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. |
|
| Part C: Dose-escalation part of Phase Ib | Experimental | Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses. |
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| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSE12 | Drug | ROSE12 as a IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 (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 (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 (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 (All Parts) | The area under the concentration time-curve (AUC) of ROSE12 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A, B, C and D) | ORR, defined as the proportion of patients with an objective response on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. | From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months) |
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Inclusion Criteria:
Exclusion Criteria:
[Expansion Part]
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical trials information | Contact | only use Email | clinical-trials@chugai-pharm.co.jp |
| Name | Affiliation | Role |
|---|---|---|
| Sponsor Chugai Pharmaceutical Co.Ltd | clinical-trials@chugai-pharm.co.jp | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States | |
| NEXT Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41513409 | Derived | 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. |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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| Atezolizumab | Drug | Atezolizumab as a IV infusion |
|
| 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 (Part E) | 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) |
| Preliminary anti-tumor activity of ROSE12 when administered as a single agent and in combination with atezolizumab (All Parts) | Disease control rate (DCR), defined as the proportion of patients who had an objective response or stable disease (SD) which is confirmed no less than 6 weeks after the start of treatment as the minimum duration, as determined by the investigator with use of RECIST v1.1. | 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 (All Parts) | Duration of objective response (DoR), defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1. | 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 (All Parts) | Progression-free survival (PFS), defined as the time from administration of first study treatment to the first occurrence of disease progression or death from any cause, as determined by the investigator according to RECIST v1.1. | 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) | The maximum serum concentration (Cmax) of atezolizumab | 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 atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E) | The minimum serum concentration (Cmin) of atezolizumab | 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 atezolizumab for PK profile when administered in combination with ROSE12 (Part C, D and E) | The area under the concentration-time curve (AUC) of atezolizumab | 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 immunogenicity of ROSE12 when administered as a single agent and in combination with atezolizumab (All Parts) | Prevalence and incidence of anti-drug antibodies (ADAs) to ROSE12 and potential correlation with PK parameters and safety | 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 immunogenicity of atezolizumab when administered in combination with ROSE12 (Part C, D and E) | Prevalence and incidence of ADAs to atezolizumab and potential correlation with PK parameters and safety | 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) |
| Recruiting |
| Fairfax |
| Virginia |
| 22031 |
| United States |
| National Cancer Center Hospital East | Recruiting | Kashiwa-shi | Chiba | 277-8577 | Japan |
| National Cancer Center Hospital | Recruiting | Chuo-ku | Tokyo | 104-0045 | Japan |