臨床研究等提出・公開システム

An Open-Label, Multicenter Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of RO7616789 in Participants With Advanced Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

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

Yoh Kiyotaka

National Cancer Center Hospital East/Department of Experimental Therapeutics

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Complete

Jan. 31, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-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

-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

Both

Small cell lung cancer and other neuroendocrine carcinoma

RO7616789: RO7616789 is administered as a intravenously at the prescribed dose in the protocol.
Tocilizumab: intravenous administration(IV), Prescribed dose

Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics
Evaluation of safety and tolerability based on NCI CTCAE
Efficacy evaluation based on RECIST

Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics
Evaluate the PK profile of RO7616789
Efficacy evaluation based on RECIST

+81-3-3542-2511

Nov. 09, 2022

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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