Tiragolumab and Atezolizumab IV FDC
DrugIntravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).
NCT Number: NCT05661578
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Chongqing Sanxia Central Hospital, Chongqing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cancer-Specific Inclusion Criteria:
Exclusion criteria
Cancer-Specific Exclusion Criteria:
Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W).
Time frame: Up to approximately 30.5 months
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 Day 21 of Cycle 1 (1 cycle=21 days)
day*µg/mL=day-micrograms per milliliter.
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: Up to Day 21 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days)
Time frame: Up to approximately 14.9 months
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
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.
Hoffmann-La Roche
Industry
A Phase II, Single-Arm, Open-Label Study Evaluating the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors
Acronym: SKYSCRAPER-11
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.