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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

Purpose

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study.

Conditions

Small Cell Lung Cancer
Neuroendocrine Carcinoma

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion 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 poorly differentiated NEC of any other origin, relapsed after at least 1 systemic therapy - 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

Exclusion Criteria

Pregnant or breastfeeding, or intending to become pregnant during the study or within 40 days after the final dose of study treatment - Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1c ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L) - QT interval corrected using Fridericia's formula (QTcF) > 470 ms. Abnormal electrocardiograms (ECGs) (triplicate) should be performed > 30 minutes apart - Current treatment with medications that are well known to prolong the QT interval - 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 - 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 - Spinal cord compression that has not been definitively treated with surgery and/or radiation - Active or history of clinically significant autoimmune disease - Positive test for human immunodeficiency virus (HIV) infection - Positive hepatitis B surface antigen (HbsAg) test, and/or positive total hepatitis B core antibody (HbcAb) test at screening - Prior allogeneic hematopoietic stem cell transplantation or prior solid organ transplantation - Administration of a live, attenuated vaccine within 4 weeks before first RO7616789 infusion - Known allergy or hypersensitivity to any component of the RO7616789 formulation

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part 1: RO7616789 QW: Dose Escalation	Participants will receive a fixed dose of RO7616789 intravenously once weekly (QW) per dose level on Day 1, 8, and 15 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.	Drug: RO7616789 RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part. Drug: Tocilizumab Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. Other names: Actemra, RoActemra
Experimental Part 2: RO7616789 Q3W: Dose Escalation	Participants will receive a fixed dose of RO7616789, at a dose determined in Part 1, intravenously once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.	Drug: RO7616789 RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part. Drug: Tocilizumab Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. Other names: Actemra, RoActemra
Experimental Part 3: Dose Expansion	Based on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3.	Drug: RO7616789 RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part. Drug: Tocilizumab Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg. Other names: Actemra, RoActemra

Recruiting Locations

Georgetown Uni Medical Center; Lombardi Cancer Center
Washington, District of Columbia 20007

More Details

Status: Recruiting
Sponsor: Hoffmann-La Roche

Study Contact

Reference Study ID Number: BP44382 https://forpatients.roche.com/
888-662-6728 (U.S. Only)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.