The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).
Medical Oncology Associates
Spokane, Washington, United States
Chongqing Sanxia Central Hospital
Chongqing, China
General Hospital Pula
Pula, Croatia
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
IASO Obstetrics Gynecology Clinic
Marousi, Greece
University General Hospital of Patras
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention.
Time frame: Up to approximately 30.5 months
Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1
day\*µg/mL=day-micrograms per milliliter.
Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)
Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
AUC0-21d of Atezolizumab at Cycle 1
Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)
AUC0-inf of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)
Maximum Concentration (Cmax) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmax of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Minimum Concentration (Cmin) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Cmin of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Total Body Clearance (CL) of Tiragolumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
CL of Atezolizumab at Cycle 1
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Time frame: Up to approximately 14.9 months
Number of Participants With ADAs to Atezolizumab
Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Time frame: Up to approximately 14.9 months
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Pátrai, Greece
St. Luke's Hospital
Thessaloniki, Greece
University Hospital Medical Center Bezanijska kosa
Belgrade, Serbia
Oncology Institute of Vojvodina
Kamenitz, Serbia
National Cancer Center
Goyang-si, South Korea
...and 22 more locations