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Report for Clinical Trial NCT03964233

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ia/Ib, Open Label, Dose-escalation Study of the Combination of BI 907828 With BI 754091 and BI 754111, Followed by Expansion Cohorts, in Patients With Advanced Solid Tumors

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


1 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 ---


2 V600E

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