A first-in-human Phase I, non-randomized, open-label, multi-center dose escalation trial of BI 765049 and BI 765049 + ezabenlimab administered by repeated intravenous infusions in patients with malignant solid tumors expressing B7-H6

MC #22-18

Colorectal Cancer, Gastric/GEJ Cancer, Head and Neck Cancer, Hepatocellular Cancer, Lung Cancer (NSCLC), Pancreatic Cancer
Molecular Target(s)
B7H6, CD3, PD-1, PD-L1
Drug Classification(s)
BI 765049: Bispecific Monoclonal Antibody ; BI 765049: Targeted Immunotherapy
  • Signed and dated, written informed consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with advanced or metastatic colorectal cancer (CRC); and 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.
  • Patient must be ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).
  • Patients with a histologically or cytologically confirmed diagnosis of an advanced, unresectable, and/or metastatic colorectal carcinoma (CRC), non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), head and neck squamous cell carcinoma (HNSCC), gastric carcinoma, and pancreatic carcinoma. At least 1 patient in each back-fill slot must be a non-CRC patient (i.e., NSCLC, HCC, HNSCC, gastric carcinoma, or pancreatic carcinoma).
  • Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, or with a tumor for which no conventional treatment exists.
  • All patients must agree to the collection of tumor samples (as slides from archival diagnostic samples or fresh tumor biopsies) for confirmation of B7-H6 expression either at Screening visit 02 (for CRC patients) or Screening visit 01 (for all other patients). To qualify for a back-fill slot or recommended dose expansion (RDE) cohort, the patient must agree to the collection of mandatory pre-treatment and on-treatment fresh tumor biopsies.
  • Patient diagnosed with advanced or metastatic CRC or patient with confirmed B7-H6 expression on tumor tissue sample (archived or fresh tumor biopsy) based on central pathology review.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient must have at least one evaluable target lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 separate from any lesion(s) identified for tumor biopsy. Tumor lesions that have been irradiated at least ≥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.

Mechanism of Action

Bl 765049 is a bispecific monoclonal antibody that binds B7 homolog 6 (B7-H6) and CD3 on T-cells.


  • How much of the study agent(s) can be given with an acceptable level of side effects
  • The effects of the study agent(s) (good and bad)
  • How much of the study agent(s) is absorbed into the blood and how fast they are removed
  • If research tests can be used in the future to predict who will benefit from the study agent(s)



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