Trial Title:
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
NCT ID:
NCT05619744
Condition:
Small Cell Lung Cancer
Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RO7616789
Description:
RO7616789 solution for infusion will be administered intravenously at a dose and per
schedule as specified for the respective part.
Arm group label:
Part 1: RO7616789 QW: Dose Escalation
Arm group label:
Part 2: RO7616789 Q3W: Dose Escalation
Arm group label:
Part 3: Dose Expansion
Intervention type:
Drug
Intervention name:
Tocilizumab
Description:
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.
Arm group label:
Part 1: RO7616789 QW: Dose Escalation
Arm group label:
Part 2: RO7616789 Q3W: Dose Escalation
Arm group label:
Part 3: Dose Expansion
Other name:
Actemra, RoActemra
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Georgetown Uni Medical Center; Lombardi Cancer Center
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital;Oncology
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital; Josephine Ford Cancer Center
Address:
City:
Detroit
Zip:
48202-2689
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
11101
Country:
United States
Status:
Recruiting
Facility:
Name:
The Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Pittsburgh Medical Center; Division of Hematology-Oncology
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Status:
Recruiting
Facility:
Name:
Rigshospitalet; Fase 1 Enhed - Onkologi
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital East; Thoracic Oncology
Address:
City:
Chiba
Zip:
277-8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Tokyo
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Address:
City:
Gda?sk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron; Oncology
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Fundacion Jimenez Diaz; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Start date:
January 23, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Hoffmann-La Roche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05619744
