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

JRCT ID: jRCT2031230596

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: B7-H6-positive GC, CRC, PDAC, HCC, HNSCC, or NSCLC patients
• Date of first enrollment: 01/02/2024
• Target sample size: 70
• Countries of recruitment: China,Japan
• Study type: Interventional
• Intervention(s): test products: BI 765049, Ezabenlimab (BI 754091)

Outcome(s)

Primary Outcome

Parts I and III
The primary endpoint for each part is
. Part I: Occurrence of DLTs during the MTD evaluation period for BI 765049 monotherapy
. Part III: Occurrence of DLTs during the MTD evaluation period for BI 765049 in combination with ezabenlimab

Parts II and Part IV
The primary endpoint is
. 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

Part I and III
The secondary endpoints are
. PK parameters of BI 765049 after the first and after multiple administrations of BI 765049
. Objective response based on RECIST v1.1 as determined by the Investigator in patients with measurable disease who have been treated with either BI 765049 monotherapy or BI 765049 in combination with ezabenlimab. Objective response is defined as the best overall response of CR or PR, from the first administration of trial medication until the earliest of PD, death, or last evaluable tumour assessment before the start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.

Part II and Part IV
The secondary endpoints are
. PFS, defined as the time from first treatment administration until tumour progression according to RECIST 1.1 as determined by the Investigator or death from any cause, whichever occurs earlier
. Duration of response, defined as the time from a patient's first documented CR or PR, according to RECIST 1.1, until the earlist of disease progression, or death
. Disease control, defined as best overall response of CR, PR or stable disease (SD) where best overall response is as determined by the Investigator according to RECIST v1.1 from the first administration of trial medication until the earliest of PD, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent.
. Objective response based on iRECIST criteria as determined by the Investigator in patients with measurable disease, defined as the best overall response of CR or PR, from the first administration of trial medication until the earliest of immune-confirmed PD, death, or last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent
. PK parameters of BI 765049 after the first and after multiple administrations of BI 765049

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable

Include criteria

. >=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

Exclude criteria

. 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.

Related Information

• Primary Sponsor: Hagimori Kenta
• Secondary ID(s): NCT06091930