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)

Phase 1

• Conditions: advanced solid tumors

• Registration Number: JPRN-jRCT2031200355
• Lead Sponsor: akajima Michiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified