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Phase I Study of Combination Therapy with OBP-301, Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma

Phase I Study of Combination Therapy with OBP-301, Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma

4

The subjects were all male, and had an ECOG PS of 0 at baseline.

A total of 4 patients were enrolled and received the OBP-301, atezolizumab and bevacizumab.

The number of subjects in whom adverse events occurred was 4/4 subjects (45 events), and in whom adverse reactions occurred was 4/4 subjects (37 events). Grade 3 or higher adverse events occurred in 1/4 subjects (6 events), and serious adverse events occurred in 3/4 subjects (4 events). Adverse events leading to discontinuation of any investigational products occurred in 2/4 subjects (2 events), and adverse events leading to dose modification or interruption of any investigational products occurred in 3/4 subjects (4 events). No deaths occurred during the study period.

Primary outcome measures: None of the subjects, including the 1 subject included the initial safety evaluation, experienced adverse events that were of questionable tolerability, but the results of this study were inconclusive for the initial safety evaluation. Secondary outcome measures: Based on RECIST, 2 subjects had a best overall response of SD, and 1 subject each had a best overall response of PD and NE. The best overall response based on mRECIST was PR, SD, PD, and NE in 1 subject each.

OBP-301, atezolizumab, and bevacizumab were administered to 4 subjects, and none of the subjects, including 1 subject included in the initial safety evaluation, experienced adverse events that were of questionable tolerability, but the results of this study were inconclusive for initial safety evaluation.

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).

https://jrct.niph.go.jp/latest-detail/jRCT2033200223

Doi Toshihiko

National Cancer Center Hospital East

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

Jan. 31, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology
Patients with cirrhosis require clinical confirmation of diagnosis based on the Clinical Practice Guidelines for Hepatocellular Carcinoma.
- Disease that is not amenable to curative surgical and/or locoregional therapies
- No prior systemic therapy (including non-approved and investigational agents) for HCC
- ECOG Performance Status of 0 or 1
- Child-Pugh class A

- Fibrolamellar HCC, sarcomatoid HCC, or a mixed type of cholangiocellular carcinoma and HCC have been confirmed.
- The patients who have history of hepatic encephalopathy
- The patients with symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Both

Hepatocellular carcinoma

OBP-301:Specified dose is administered transdermally.
Atezolizumab :1200 mg IV infusion Q3W
Bevacizumab:15 mg/kg IV infusion Q3W

Safety
Observation

Efficacy
Tumor assessment, Observation

+81-3-3542-2511

Dec. 02, 2020

none