SNPMiner Trials (Home Page)
Report for Clinical Trial NCT03964233
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Phase Ia - Dose Escalation
The main objective of the dose-escalation part is to determine the maximum tolerated dose
(MTD) of BI 907828 in combination with BI 754091 and BI 754111, based on the frequency of
patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for
further development of BI 907828 in combination with BI 754091 and BI 754111, and to evaluate
safety and tolerability of BI 907828 in combination with BI 754091 and BI 754111 by
monitoring the occurrence and severity of adverse events (AEs).
The secondary objectives are the determination of the pharmacokinetic (PK) profile of BI
907828, BI 754091 and BI 754111 based on Cmax and AUC0-tz, and the preliminary assessment of
anti-tumor activity.
Phase Ib - Dose Expansion
The main objective of the dose-expansion part is to assess the preliminary efficacy of the
combination of BI 907828, BI 754091, and BI 754111.
The secondary and further objectives are to further assess the safety, the PK profiles at the
recommended dose for expansion (RDE), and to determine the Recommended Phase II Dose (RP2D).
NCT03964233 Neoplasms
3 Interventions
Name: BI 907828
Description: Film-coated tablets
Type: Drug
Group Labels: 6 Dose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1 - Arm C - BI 907828 + BI 754091 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Name: BI 754091
Description: Solution for infusion
Type: Drug
Group Labels: 7 Dose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1 - Arm B - BI 754091 + BI 754111 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+B Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Name: BI 754111
Description: Solution for infusion
Type: Drug
Group Labels: 6 Dose Escalation - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 1 - Arm B - BI 754091 + BI 754111 Dose Expansion - Cohort 1-Arm A -BI 907828+BI 754091+BI 754111 Dose Expansion - Cohort 2 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 3 - BI 907828 + BI 754091 + BI 754111 Dose Expansion - Cohort 4 - BI 907828 + BI 754091 + BI 754111
Primary Outcomes
Measure: Phase Ia - maximum tolerated dose (MTD) of BI 907828 in combination with BI 754091 and BI 754111 based on the number of patients with DLTs during the first treatment cycle Time: Up to 35 Days
Measure: Phase Ib - Objective response (OR) Time: Up to 24 months
Secondary Outcomes
Measure: Phase Ia - Cmax : Maximum measured plasma concentration of BI 907828, BI 754091, and BI 754111 (during the first cycle) Time: Up to 21 Days
Measure: Phase Ia - AUC0-tz: Area under the concentration-time curve in plasma for BI 907828, BI 754091 and BI 754111 over the time interval from 0 to the last quantifiable time point (during the first cycle) Time: Up to 21 Days
Measure: Phase Ia - Number of patients with DLTs observed during the entire treatment period Time: Up to 24 months
Measure: Phase Ib - Objective Response (OR) Time: Up to 24 months
Measure: Phase Ib - Disease control (DC) Time: Up to 24 months
Measure: Phase Ib - Progression-Free Survival (PFS) Time: Up to 24 months
Measure: Phase Ib - In cohort 3 (liposarcoma and undifferentiated pleomorphic sarcoma): PFS rate at 12 and 24 weeks Time: 12 and 24 weeks
Measure: Phase Ib - Number of patients with DLTs Time: Up to 2 years
Purpose: Treatment
Allocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
SNPs
Patients with NSCLC harboring genomic aberrations for which FDA approved targeted
therapy is available such as non-resistant EGFR mutations, EGFR T790M mutation,
ALK rearrangement, ROS re-arrangement, and BRAF V600E mutation, must have
received prior treatment with FDA-approved targeted therapy. --- T790M ---
Patients with NSCLC harboring genomic aberrations for which FDA approved targeted
therapy is available such as non-resistant EGFR mutations, EGFR T790M mutation,
ALK rearrangement, ROS re-arrangement, and BRAF V600E mutation, must have
received prior treatment with FDA-approved targeted therapy. --- T790M --- --- V600E ---
HPO Nodes