JRCT ID: jRCT2031220511
Registered date:14/12/2022
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of RO7616789 in Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | Small cell lung cancer and other neuroendocrine carcinoma |
Date of first enrollment | 23/01/2023 |
Target sample size | 168 |
Countries of recruitment | United States,Japan |
Study type | Interventional |
Intervention(s) | RO7616789: RO7616789 is administered as a intravenously at the prescribed dose in the protocol. Tocilizumab: intravenous administration(IV), Prescribed dose |
Outcome(s)
Primary Outcome | Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics Evaluation of safety and tolerability based on NCI CTCAE Efficacy evaluation based on RECIST |
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Secondary Outcome | Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics Evaluate the PK profile of RO7616789 Efficacy evaluation based on RECIST |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | -Life expectancy at least 12 weeks -Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1 -Adequate hematologic and end organ function -Negative serum pregnancy test. -Adequate contraception and no or interruption of breastfeeding -Histologically confirmed extensive SCLC or high grade NEC of any other origin that have relapsed after at least 1 systemic therapy and for which standard therapy has proven to be i-neffective or intolerable or is considered inappropriate. -Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1 -Confirmed availability of representative archival tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or unstained slides |
Exclude criteria | -History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti-tumor treatment, or leptomeningeal disease and current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease -Active or history of clinically significant autoimmune disease -Positive test for human immunodeficiency virus (HIV) infection -Active hepatitis B or hepatitis C -Prior treatment with anti-cluster of differentiation (CD)137 agents, anti-CD3 agents and/or delta-like ligand 3 (DLL3) targeted therapies -Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 21 days prior to initiation of study treatment -Any history of an immune-related Grade 4 adverse event (AE) attributed to prior anti-programmed death ligand-1 (PD-L1) /PD-1 or anti-cytotoxic T-lymphocyte-associated protein (CTLA-4) therapy (other than asymptomatic elevation of serum amylase or lipase) -Any history of an immune-related Grade 3 adverse event attributed to prior anti-PD-L1 /PD-1 or anti-CTLA-4 therapy (other than asymptomatic elevation of serum amylase or lipase) that resulted in permanent discontinuation of the prior immunotherapeutic agent -Administration of a live, attenuated vaccine within 4 weeks before first RO7616789 infusion |
Related Information
Primary Sponsor | Yoh Kiyotaka |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05619744 |
Contact
Public contact | |
Name | Clinical trials information |
Address | 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | Chugai Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | Kiyotaka Yoh |
Address | 1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo Tokyo Japan 103-8324 |
Telephone | +81-120-189-706 |
clinical-trials@chugai-pharm.co.jp | |
Affiliation | National Cancer Center Hospital East/Department of Experimental Therapeutics |