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A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-181, a Monoclonal Antibody, as Monotherapy and in Combination With Another Anti-Cancer Therapy in Subjects With Advanced Solid Tumors
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-181. This study will also evaluate the safety and tolerability of ABBV-181 in combination with Rovalpituzumab Tesirine. The study will consist of 2 parts: ABBV-181 monotherapy dose escalation and expansion, and ABBV-181 in combination with Rovalpituzumab Tesirine. In the Monotherapy portion of the study, ABBV-181 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Based on available safety, pharmacokinetic, and pharmacodynamic data from the dose-escalation part of the study, participants will be enrolled in tumor-specific dose-expansion cohorts to further evaluate ABBV-181 at a dose level which is at or below the Maximum tolerated dose (MTD).
In the Combination portion of the study, ABBV-181 will be administered in combination with Rovalpituzumab Tesirine in 21-day dosing cycles. Based on available safety, PK and PD data from the single agent dose-escalation part of the study, a dose for ABBV-181 will be selected to evaluate in combination with Rovalpituzumab Tesirine. In the second arm of the study, Rovalpituzumab Tesirine will be given once every six weeks times two doses and ABBV-181 will be administered every 3 weeks.