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
- Conditions
- Small cell lung cancer and other neuroendocrine carcinoma
- Registration Number
- JPRN-jRCT2031220511
- Lead Sponsor
- Yoh Kiyotaka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 168
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics<br>Evaluation of safety and tolerability based on NCI CTCAE<br>Efficacy evaluation based on RECIST
- Secondary Outcome Measures
Name Time Method Safety, Efficacy, Exploratory, Phamacokinetics, Phamacodynamics<br>Evaluate the PK profile of RO7616789<br>Efficacy evaluation based on RECIST