臨床研究等提出・公開システム

An open-label, Phase I trial to determine the maximum-tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 905677 administered intravenously in patients with advanced solid tumours

This study aims to find and test a safe dose of BI 905677 in patients with different types of cancer (solid tumours)

Nippon Boehringer Ingelheim Co., Ltd.

https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

Nippon Boehringer Ingelheim Co., Ltd.

https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

terminated

Aug. 10, 2018

Interventional

Open-label, single arm, dose escalation

treatment purpose

1

* Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy. Patient must have measurable or evaluable lesions (according to RECIST 1.1).
* Eastern Cooperative Oncology Group score of 0 or 1
* Adequate organ function at the liver, kidneys and bone marrow
etc.

* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to first trial treatment or planned within 6 months after screening.
* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years.
* Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
etc.

Both

Advanced solid tumours (tumors harboring either RNF43 mutation or R-spondin [RSPO2 or RSPO3] fusion was demonstrated the non-clinical proof of concept but not limited such a mutation status for this trial participation.)

investigational material(s)
Generic name etc : BI 905677
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

safety
The MTD of BI 905677 and number of patients experiencing adverse events (AEs) during the entire treatment period. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to CTCAE Version 5.0, in the first cycle of treatment (3 weeks in Schedule A and 4 weeks in Schedule B). Separate MTDs will be determined for Schedule A and Schedule B.

pharmacokinetics
The following PK parameters of BI 905677 will be evaluated after the first
administration of BI 905677:
Cmax: maximum measured concentration of BI 905677 in serum after first infusion
AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz)

Sept. 26, 2018