This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 in subjects with advanced solid tumors. Enrollment is closed for Arms A and D.
Name: Osimertinib
Description: It is administered orally everyday.Type: DrugArm E (ABBV-399 plus Osimertinib)
Name: Nivolumab
Description: It is an intravenous infusion administered every 14 days.Type: DrugArm D (ABBV-399 plus Nivolumab)
Name: ABBV-399
Description: It is administered by infusion in 21-day dosing cycles.Type: DrugMonotherapy ABBV-399 (21-day dosing cycles) Arm A (ABBV-399 plus Erlotinib)
Name: ABBV-399
Description: It is administered by infusion in 28-day dosing cycles.Type: DrugArm E (ABBV-399 plus Osimertinib) Monotherapy ABBV-399 (28-day dosing cycles) Arm D (ABBV-399 plus Nivolumab)
Name: Erlotinib
Description: It is administered orally everyday.Type: DrugArm A (ABBV-399 plus Erlotinib)
Description: AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) Time: Up to 24 monthsDescription: Maximum observed plasma concentration (Cmax)
Measure: Maximum observed plasma concentration (Cmax) Time: Up to 24 monthsDescription: Time to Cmax (Tmax)
Measure: Time to Cmax (Tmax) Time: Up to 24 monthsDescription: ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR).
Measure: Objective response rate (ORR) Time: Up to 24 monthsDescription: PFS is defined as the time from the first dose date of ABBV-399 to either disease progression or death, whichever occurs first.
Measure: Progression free survival (PFS) Time: Up to 24 monthsDescription: DOR is defined as the time from the subject's initial CR or PR to the time of disease progression.
Measure: Duration of overall response (DOR) Time: Up to 24 monthsAllocation: Non-Randomized
Single Group Assignment
There are 2 SNPs
- Subject must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q. --- L858R ---
- Subject must have metastatic NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) known to be sensitive to osimertinib, including del19, L858R, G719X or L861Q. --- L858R --- --- L861Q ---