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

Phase 1

Completed

• Conditions: Neoplasms
• Interventions: Drug: BI 905681

• Registration Number: NCT04147247
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Study was opened to recruitment until 29-Oct-2021, however from 15-Apr-2021 no patient was recruited.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Study Start: 2019-12-23
• Primary Completion: 2021-05-06
• Study Completion: 2021-05-27
• Results First Submitted: 2023-01-23
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-28
• Last Update Submitted: 2023-11-28
• Results First Posted: 2023-11-29
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
5.0 milligram/kilogram BI 905681	BI 905681	Subjects received an intravenous infusion of 5.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
7.0 milligram/kilogram BI 905681	BI 905681	Subjects received an intravenous infusion of 7.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
8.5 milligram/kilogram BI 905681	BI 905681	Subjects received an intravenous infusion of 8.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
2.5 milligram/kilogram BI 905681	BI 905681	Subjects received an intravenous infusion of 2.5 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.
1.0 milligram/kilogram BI 905681	BI 905681	Subjects received an intravenous infusion of 1.0 milligram/kilogram BI 905681 on day 1 of each cycle (1 cycle = 21 days). Patients may continue on treatment for unlimited cycles, until criteria for stopping treatment are met.

Primary Outcome Measures

Name	Time	Method
Number of Patients Experiencing Adverse Events (AEs) During the Entire Treatment Period	From the first administration of study till the last administration of study drug +42 days, up to 126 days.	Number of patients experiencing adverse events (AEs) during the entire treatment period.
The Maximum Tolerated Dose (MTD)/Optimal Biological Dose (OBD) of BI 905681	The first cycle of treatment, up to 21 days.	The MTD/OBD of BI 905681. The MTD will be assessed based on the number of patients experiencing Dose Limiting Toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, in the first cycle of treatment (3 weeks). The MTD is defined as the highest dose with less than 25% risk of the true DLT rate being equal to or above 33%.

Secondary Outcome Measures

Name	Time	Method
Cmax: Maximum Measured Concentration of BI 905681 in Serum After First Infusion	5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.	Cmax: maximum measured concentration of BI 905681 in serum after first infusion.
AUC0-tz: Area Under the Serum Concentration-time Curve Over the Time Interval From 0 to the Last Measured Time Point (tz)	5 minutes before and 1, 1.5, 4, 8, 24, 72, 168, 336 and 504 (5 minutes before 2nd infusion) hours following the first infusion.	AUC0-tz: area under the serum concentration-time curve over the time interval from 0 to the last measured time point (tz).

Trial Locations

Locations (3)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States