This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
Name: Osimertinib
Name: Nivolumab
Name: Telisotuzumab vedotin
Name: Telisotuzumab vedotin
Name: Erlotinib
Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measure: Number of Participants with Adverse Events Time: Up to 24 MonthsDescription: The RPTD of ABBV-399 when administered as monotherapy and in combination with osimertinib, erlotinib or nivolumab will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data.
Measure: Recommended Phase 2 Dose (RPTD) of ABBV-399 when Administered as Monotherapy and in Combination with Osimertinib, Erlotinib or Nivolumab Time: Up to 24 MonthsDescription: 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: Terminal elimination half life.
Measure: Terminal elimination half life Time: Up to 24 monthsAllocation: Non-Randomized
Sequential Assignment
There are 2 SNPs
- Participant must have metastatic/locally advanced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resistant to osimertinib. --- L858R ---
- Participant must have metastatic/locally advanced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resistant to osimertinib. --- L858R --- --- T790M ---