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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508489-14-00

Acronym

GO44096

Enrollment

Registered

2024-02-20

Start date

2023-09-18

Completion date

2025-11-24

Last updated

2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Brief summary

1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) – The severity of CRS will also be determined according to the ASTCTCRS American Society for Transplantation and Cellular Therapy cytokine release syndrome Consensus Grading Scale.

Detailed description

1. Area under the concentration time curve of tiragolumab and atezolizumab at Cycle 1, 2. Maximum serum concentration (Cmax) of tiragolumab and atezolizumab at Cycle 1, 3. Minimum serum concentration (Cmin) of tiragolumab and atezolizumab at Cycle 1, 4. Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and the incidence of treatment emergent ADAs to tiragolumab during the study, 5. Prevalence of ADAs to atezolizumab at baseline and the incidence of treatment emergent ADAs to atezolizumab during the study

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) – The severity of CRS will also be determined according to the ASTCTCRS American Society for Transplantation and Cellular Therapy cytokine release syndrome Consensus Grading Scale.	—

Secondary

Measure	Time frame
1. Area under the concentration time curve of tiragolumab and atezolizumab at Cycle 1, 2. Maximum serum concentration (Cmax) of tiragolumab and atezolizumab at Cycle 1, 3. Minimum serum concentration (Cmin) of tiragolumab and atezolizumab at Cycle 1, 4. Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and the incidence of treatment emergent ADAs to tiragolumab during the study, 5. Prevalence of ADAs to atezolizumab at baseline and the incidence of treatment emergent ADAs to atezolizumab during the study	—

Measure

Time frame

—

Countries

Croatia, Cyprus, Greece, Spain

Outcome results