Clinical Trials /

A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread

NCT04147247

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
  • Official Title: An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905681 Administered Intravenously in Patients With Advanced Solid Tumours

Clinical Trial IDs

  • ORG STUDY ID: 1424-0001
  • SECONDARY ID: 2019-003490-25
  • NCT ID: NCT04147247

Conditions

  • Neoplasms

Interventions

DrugSynonymsArms
BI 905681BI 905681

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
BI 905681Experimental
  • 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681
Time Frame:Up to 4 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Cmax: maximum measured concentration of BI 905681 in serum after first infusion
Time Frame:18 months
Safety Issue:
Description:
Measure:AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz)
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boehringer Ingelheim

Last Updated

June 4, 2020