臨床研究等提出・公開システム

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

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

Tien Hoang

F. Hoffmann-La Roche Ltd

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Complete

Feb. 28, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

prevention purpose

- 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

Both

locally advanced, recurrent, or metastatic tumors

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

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)

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

+81-3-3542-2511

Nov. 12, 2021

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

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