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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
RO7616789 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective part.
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.
Georgetown Uni Medical Center
Washington D.C., District of Columbia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 7 more locations
Part 1, 2 and 3: Number of Participants with Adverse Events and Serious Adverse Events
Adverse events were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0), and Cytokine release syndrome (CRS), will be graded based on the American Society for Transplantation and Cell Therapy (ASTCT) criteria.
Time frame: Up to approximately 26 months
Part 1 and 2: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Day 1 through Day 21 in cycle 1 (Cycle is 21 days)
Part 3: Objective Response Rate (ORR) as determined by Investigator
Time frame: Up to approximately 26 months
Part 3: Disease Control Rates as Determined by the Investigator
Time frame: Up to approximately 26 months
Part 3: Duration of Response (DOR) as Determined by the Investigator
Time frame: Up to approximately 26 months
Part 3: Progression Free Survival (PFS) as Determined by the Investigator
Time frame: Up to approximately 26 months
Part 3: Overall Survival (OS)
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Serum Concentration of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Maximum Serum Concentration (Cmax) of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Area Under the Concentration-Time Curve (AUC) of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Total Clearance of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Terminal Half-Life of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Volume of Distribution of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Time to Reach Steady State Concentration of RO7616789
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Accumulation Ratio of RO7616789
Time frame: Up to approximately 26 months
Part 1 and 2: ORR as Determined by the Investigators
Time frame: Up to approximately 26 months
Part 1 and 2: Disease Control Rates as Determined by the Investigator
Time frame: Up to approximately 26 months
Part 1 and 2: DOR as Determined by the Investigators
Time frame: Up to approximately 26 months
Part 1 and 2: PFS as Determined by the Investigators
Time frame: Up to approximately 26 months
Part 1 and 2: OS as Determined by the Investigators
Time frame: Up to approximately 26 months
Part 1, 2 and 3: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7616789
Time frame: Up to approximately 26 months
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