A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
Condition: Neoplasms
Intervention: BI 905681
Intervention description: Infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal
      biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the
      recommended dose and dosing schedule for further trials in the development of BI 905681. The
      MTD will be defined based on the frequency of patients experiencing dose-limiting toxicities
      (DLTs) during the MTD/DLT evaluation period, which is defined as the first cycle of
      treatment. Separate MTDs will be determined for Schedule A and Schedule B.

      The secondary objective of the trial is to determine the pharmacokinetic (PK) profile of BI
      905681.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically or cytologically confirmed diagnosis of an advanced, unresectable
             and/or metastatic non-haematologic malignancy. Patient must have measurable or
             evaluable lesions (according to Response Evaluation Criteria in Solid Tumours (RECIST)
             v 1.1).

          -  Patient who has failed conventional treatment or for whom no therapy of proven
             efficacy exists or who is not eligible for established treatment options.

          -  Patients willing to undergo mandatory tumour biopsy at the time points specified in
             the protocol.

          -  Eastern Cooperative Oncology Group (ECOG) Score of 0 or 1 (R01-0787).

          -  Adequate organ function defined as all of the following:

               -  Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; haemoglobin ≥9.0 g/dL; platelets
                  ≥100 x 10^9/L without the use of haematopoietic growth factors within 4 weeks of
                  start of study medication.

               -  Total bilirubin ≤1.5 x the upper limit of normal (ULN), except for patients with
                  Gilbert's syndrome: total bilirubin ≤3 x ULN or direct bilirubin ≤1.5 x ULN.

               -  Creatinine ≤1.5 x ULN. If creatinine is >1.5 x ULN, patient is eligible if
                  concurrent creatinine clearance ≥50 ml/min (measured or calculated by the Chronic
                  Kidney Disease Epidemiology Collaboration (CKD-EPI) formula or Japanese version
                  of CKD-EPI formula for Japanese patients).

               -  Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN if no
                  demonstrable liver metastases, or otherwise ≤5 x ULN

               -  Alkaline Phosphatase (ALP) <5 x ULN

          -  At least 18 years of age at the time of consent or over the legal age of consent in
             countries where that is greater than 18 years.

          -  Signed and dated written informed consent in accordance with International Conference
             on Harmonisation (ICH) - Good Clinical Practice (GCP) and local legislation prior to
             admission to the trial

          -  Life expectancy ≥3 months at the start of treatment in the opinion of the investigator

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Osteoporosis ≥ CTCAE Grade 2

          -  Osteoporotic compression fracture within 12 months prior to informed consent which is
             clinically significant in the opinion of the investigator.

          -  Further exclusion criteria apply