This study aims to find and test a safe dose of BI 905677 in patients with different types of cancer (solid tumours)
- Conditions
- 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.)
- Registration Number
- JPRN-jRCT2080224086
- Lead Sponsor
- ippon Boehringer Ingelheim Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 37
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>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.
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>The following PK parameters of BI 905677 will be evaluated after the first<br>administration of BI 905677:<br>Cmax: maximum measured concentration of BI 905677 in serum after first infusion<br>AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz)