Testing doses of BI 765049 with ezabenlimab in Asian patients with advanced cancer

Phase I, Non-randomised, Open-label, Multi-centre Dose Escalation and Expansion Trial of BI 765049 and BI 765049 + Ezabenlimab Administered by Repeated Intravenous Infusion in Asian Patients With Malignant Solid Tumours Expressing B7-H6

This study is testing a new treatment combination for Asian adults with advanced cancers that haven't responded to other therapies to see if it can help shrink their tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Drugs / interventions: ezabenlimab
• Locations: 5 sites (Jinan and 4 other locations)
• Trial ID: NCT06091930 on ClinicalTrials.gov

What this trial studies

This study focuses on adults from Asia who have advanced solid tumors, including gastrointestinal, lung, pancreatic, colorectal, and head and neck cancers. Participants must have tumors that express the B7-H6 marker and have either not responded to previous treatments or have no available treatment options. The study aims to determine the highest tolerable dose of BI 765049, both alone and in combination with ezabenlimab, while also assessing the potential for tumor shrinkage. Participants will receive infusions every three weeks and can remain in the study for up to three years if they continue to tolerate the treatment and show potential benefits.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced, unresectable, or metastatic gastrointestinal, lung, pancreatic, colorectal, head and neck cancers that express the B7-H6 marker.

Not a fit: Patients with early-stage cancers or those who have not progressed despite conventional treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced cancers that currently have limited or no effective therapies.

How similar studies have performed: While this approach is novel in its specific combination and target population, similar studies targeting immune modulation in advanced cancers have shown promise.

Eligibility criteria

Inclusion Criteria:

* Signed and dated, written inform consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with colorectal cancer (CRC); ICF2 for all patients) describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
* ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
* Histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic gastrointestinal cancer, colorectal cancer, pancreatic cancer, liver cancer, head and neck cancer, or lung cancer.
* Disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, or with a tumour for which no conventional treatment exists.
* Agree to the collection of tumour samples (as slides from archival diagnostic samples or fresh tumour biopsies) for confirmation of B7-H6 expression at Screening Visit 02 for colorectal cancer (CRC) patients or at Screening Visit 01 for all other patients.
* 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 colorectal cancer (CRC).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* At least one evaluable target lesion as defined per response evaluation criteria in solid tumors (RECIST v1.1), outside of the central nervous system (CNS), separate from any lesion(s) identified for tumour biopsy. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions only in the absence of measurable lesions that have not been irradiated.
* Further inclusion criteria apply

Exclusion Criteria:

* History of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's assessment).
* Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

  * Effectively treated non-melanoma skin cancers
  * Effectively treated carcinoma in situ of the cervix
  * Effectively treated ductal carcinoma in situ
  * Other effectively treated malignancy that is considered cured by local treatment
* Known leptomeningeal disease or spinal cord compression due to disease.
* Require anticoagulant treatment which cannot be safely interrupted, if medically needed for a study procedure (e.g., biopsy) based on the opinion of the Investigator.
* Hepatitis C virus (HCV) infection, defined as:

  * Currently receiving curative antiviral treatment for HCV infection, and/or
  * HCV viral load is above the limit of quantification (HCV Ribonucleic acid (RNA) positive)
* Hepatitis B virus (HBV) infection with the following laboratory evidence: positive results of hepatitis B surface (HBs) antigen and presence of Hepatitis B core (HBc) antibody together with HBV-deoxyribonucleic acid (DNA).
* Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 hours prior to first dose of trial medication are not eligible.
* Patients with known history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria:

  * Cluster of differentiation 4 (CD4+) count \<350 cells/μL (local lab assessment)
  * Viral load \>400 copies/mL (local lab assessment)
  * Not receiving antiretroviral therapy
  * Receiving established antiretroviral therapy for less than four weeks prior to the start of study treatment
  * History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of study treatment Patients with a history of HIV who do not meet any of the criteria above are eligible to participate, but the patient must be under the care of a HIV/Infectious Diseases specialist, or a HIV/Infectious Diseases specialist must be consulted prior to inclusion.
* Further exclusion criteria apply

Where this trial is running

Jinan and 4 other locations

• Shandong Cancer Hospital — Jinan, China (Not_yet_recruiting)
• Shanghai East Hospital — Shanghai, China (Not_yet_recruiting)
• National Cancer Center Hospital East — Chiba, Kashiwa, Japan (Recruiting)
• National Cancer Center Hospital — Tokyo, Chuo-ku, Japan (Recruiting)
• Japanese Foundation for Cancer Research — Tokyo, Koto-ku, Japan (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Gastrointestinal Cancer; Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Head and Neck Cancer; Liver Cancer