A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumors

JRCT ID: jRCT2031210432

Registered date:19/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: locally advanced, recurrent, or metastatic tumors
• Date of first enrollment: 09/03/2022
• Target sample size: 660
• Countries of recruitment: United States,Japan,Australia,Japan,Canada,Japan,France,Japan,Italy,Japan,Korea,Japan,Spain,Japan
• Study type: Interventional

Intervention(s)

Tiragolumab: 840 mg administered by IV infusion every 4 weeks
Atezolizumab: 1680 mg administered by IV infusion every 4 weeks

Outcome(s)

Primary Outcome

Safety, Phamacokinetics
- Incidence of Dose-limiting Toxicities
- Incidence of adverse events graded according to NCI CTCAE v4.0
- Number of cycles received
- Incidence of anti-tiragolumab antibodies (Phase Ia or Ib)
- Incidence of anti-atezolizmab antibodies (Phase Ib)

Secondary Outcome

Efficacy, Exploratory, Phamacokinetics
- Pharmacokinetic parameters (e.g. AUC, Cmax)
- Activity objective per RECIST v1.1 including Objective response, Duration of objective response (DoR) and PFS
- Overall survival (OS)
- Exploratory biomarker objectives

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- ECOG PS of Grade 0 or 1
- Adequate hematologic and end-organ function
- Histologic documentated locally advanced, recurrent, or metastatic malignancy
- Patients with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or more than 15 unstained slides
- Measurable disease according to RECIST v1.1

Exclude criteria

- Leptomeningeal disease
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on Screening chest computed tomograph (CT) scan
- History of autoimmune disease
- Positive human immunodeficiency virus (HIV) test
- Active hepatitis B or C, or tuberculosis
- Severe infection within 4 weeks prior to randomization
- Prior allogeneic bone marrow or solid organ transplant
- Significant cardiovascular disease
- Known clinically significant liver disease

Related Information

• Primary Sponsor: Tien Hoang
• Secondary ID(s): NCT02794571