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.
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
Interventions
Drug | Synonyms | Arms |
---|
BI 905681 | | BI 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
Name | Type | Description | Interventions |
---|
BI 905681 | Experimental | | |
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
August 10, 2021