A study to find the best dose of BI 836880 alone and in combination with BI 754091 in Japanese patients with different types of advanced cancer

An open label, Phase I study of BI 836880 monotherapy and combination therapy of BI 836880 and BI 754091 in Japanese patients with advanced solid tumours

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224681

Enrollment

Registered

2019-05-14

Start date

2019-06-17

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

Interventions

investigational material(s) Generic name etc : BI 836880, BI 754091 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial. 2. Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type).

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to the trial drugs or their excipients 2. Known HIV, HBV, or HCV infection 3. History of severe hypersensitivity reactions to other mAbs

Design outcomes

Primary

Measure	Time frame
safety - MTD. - Number of patients with DLTs in the MTD evaluation period.	—

Secondary

Measure	Time frame
pharmacokinetics PK parameters	—

Countries

Japan

Outcome results

None listed

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