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
- Conditions
- locally advanced, recurrent, or metastatic tumors
- Registration Number
- JPRN-jRCT2031210432
- Lead Sponsor
- Tien Hoang
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 660
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Phamacokinetics<br>- Incidence of Dose-limiting Toxicities<br>- Incidence of adverse events graded according to NCI CTCAE v4.0<br>- Number of cycles received<br>- Incidence of anti-tiragolumab antibodies (Phase Ia or Ib)<br>- Incidence of anti-atezolizmab antibodies (Phase Ib)
- Secondary Outcome Measures
Name Time Method Efficacy, Exploratory, Phamacokinetics<br>- Pharmacokinetic parameters (e.g. AUC, Cmax)<br>- Activity objective per RECIST v1.1 including Objective response, Duration of objective response (DoR) and PFS<br>- Overall survival (OS)<br>- Exploratory biomarker objectives