A study to test different doses of BI 765049 alone and in combination with ezabenlimab in Asian people with advanced cancer (solid tumours) positive for B7-H6
- Conditions
- B7-H6-positive GC, CRC, PDAC, HCC, HNSCC, or NSCLC patients
- Registration Number
- JPRN-jRCT2031230596
- Lead Sponsor
- Hagimori Kenta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 70
. >=18 years of age.
. Histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic GC, CRC, PDAC, HCC, HNSCC, or NSCLC.
. Agree to the collection of tumour samples (as slides from archival diagnostic samples or fresh tumour biopsies) for confirmation of B7-H6 expression
. Confirmed B7-H6 expression on tumour tissue sample (archived or fresh tumour biopsy) based on central pathology review except for patients diagnosed with advanced or metastatic CRC
. Patient who has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options.
. Evaluable target lesion for response assessment outside of the central nervous system as defined per RECIST v1.1.
. Adequate organ function as specified in Section 3.3.2
. Any investigational or antitumour treatment within 21 days or 5 half-life periods prior to the first treatment, whichever is shorter.
. Previous treatment with a B7-H6 targeting agent
. For Parts III and IV, prior intolerable toxicity (as judged by the Investigator) to PD-1 or anti-PD-L1 therapy.
. Diagnosis of immunodeficiency within 7 days prior to the first dose of BI 765049
. History of immunosuppressive medication within 14 days prior to the first dose of BI 765049, with some exceptions
. Persistent toxicity from previous treatments (including irAEs) that has not resolved to Grade 1, except for alopecia, Grade 2 neuropathy, or endocrinopathies controlled by replacement therapy
. Evidence of active, non-treatment related autoimmune disease, with some exceptions.
. History of/active non-infectious pneumonitis or interstitial lung disease of any grade
. Infection requiring systemic antimicrobial, antiviral, antiparasitic or antifungal therapy at the start of treatment in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parts I and III<br>The primary endpoint for each part is<br>. Part I: Occurrence of DLTs during the MTD evaluation period for BI 765049 monotherapy <br>. Part III: Occurrence of DLTs during the MTD evaluation period for BI 765049 in combination with ezabenlimab<br><br>Parts II and Part IV<br>The primary endpoint is<br>. Objective response based on RECIST (v1.1) as determined by the Investigator in patients with measurable disease, defined as the best overall response of complete response (CR) or partial response (PR), from the first administration of trial medication until the earliest of progressive disease (PD), death, last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.
- Secondary Outcome Measures
Name Time Method