A study to test different doses of BI 765063 alone and in combination with BI 754091 in Japanese patients with different types of advanced cancer (solid tumors)

An open label, Phase I study of BI 765063 monotherapy, and its combination therapy with BI 754091, to characterize safety, pharmacokinetics, and pharmacodynamics in Japanese patients with advanced solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200355

Enrollment

Registered

2021-02-09

Start date

2020-12-16

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 tumors

Interventions

BI 765063 and BI 754091 (Part B only). Part A: - BI 765063: starting dose 12 mg/kg every three weeks Part B: - BI 765063: starting dose MTD-1* every three weeks - BI 754091: fixed dose of 240 mg *MTD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with the SIRPa V1 allele, i.e. either homozygous V1/V1 or heterozygous V1/V2 individuals Patients with histologically or cytologically documented advanced/metastatic primary, or recurrent, solid tumors and whose tumor progressed on or who are not eligible for standard therapy Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Presence of at least one measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1 Patients who agree to pre- and on-treatment tumor biopsies.

Exclusion criteria

Exclusion criteria: - Patients without at least one SIRPa V1 allele, i.e. homozygous SIRPa V2/V2 individuals - Presence of invasive cancers, other than the one treated in this trial, within 5 years prior to screening - HIV, HBV, or HCV infection - Active, known or suspected, autoimmune disease - Patients who have interstitial lung disease or active non-infectious pneumonitis - Serious concomitant disease or medical or psychiatric condition affecting compliance with trial requirements - Patients with symptomatic/active brain metastases

Design outcomes

Primary

Measure	Time frame
- MTD - Number of patients with Dose Limiting Toxicities (DLTs) in the MTD evaluation period. Dose limiting toxicity will be based on the toxicities observed during the first 3 weeks of study treatment (i.e., Cycle 1: from D1 to D21). Toxicities will be assessed weekly during	—

Secondary

Measure	Time frame
- Number of patients with DLTs observed during the whole study treatment period - Number of patients with adverse events (AEs), serious adverse events (SAEs) and immune-related adverse events (irAEs) during the whole study treatment period - Cmax and AUC0-tz for BI 765063 (Part A and B) and BI 754091 (Part B)	—

Contacts

Public ContactAiko Watabe

Boehringer Ingelheim

ctinfo@boehringer-ingelheim.com+81-120-189-779

Outcome results

None listed

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