Phase I study of RO7119929 given orally to participants with unresectable advanced or metastatic primary liver cancers and other solid tumors with predominant liver involvement. The primary objective of the study is to explore the safety and to determine the maximum tolerated dose (MTD) and/or optimal biologic dose (OBD) of RO7119929 as single agent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
RO7119929 will be administered orally as a capsule
Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome. Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants \> 30 kg: 8 mg/kg, for participants \< 30 kg: 12mg/kg IV
City of Hope Cancer Center
Duarte, California, United States
Rigshospitalet; Onkologisk Klinik
København Ø, Denmark
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona, Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología
Madrid, Spain
National Taiwan Uni Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Number of Participants With Dose-Limiting Toxicities (DLT)
A DLT is defined as a clinically significant AE (classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v.5.0) or significant laboratory abnormality 1) occurring during an assessment period of 21 days or 28 days after first dose of study treatment, respectively, and 2) is not attributed to disease progression, concomitant illness or another clearly identifiable cause.
Time frame: Baseline up to approximately 14 months
Number of Participants With Adverse Events (AEs) According To NCI CTCAE v5.0
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Baseline up to approximately 14 months
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Maximum Concentration (Cmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Time of Maximum Concentration Observed (Tmax) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Area Under the Curve (AUC) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929
Time frame: Cycle 1, after 1st dose, Cycle 2, after 4th dose (Each cycle is 21 days)
Half-Life (T1/2) for RO7119929 Following Administration of RO7119929, Oral Step-Up Dose
Time frame: Cycle 1 Day 15, Cycle 2 Day 1 (Cycle duration is 21 days)
Progression-Free Survival (PFS) According to RECIST v1.1
Progression-free survival (PFS) is defined as the time from randomization to disease progression or death from any cause.
Time frame: Baseline up to approximately 14 months
Objective Response Rate (ORR) According to RECIST v1.1
ORR is defined as the number of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more).
Time frame: Baseline up to approximately 14 months
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death
Time frame: Baseline up to approximately 14 months
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