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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224086

Enrollment

Registered

2018-10-09

Start date

2018-08-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.)

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * 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.

Exclusion criteria

Exclusion criteria: * 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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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)	—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026