A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumours

Official Title

A Multicentre, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumours

Summary:

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumours.

Trial Description

Primary Outcome:

• Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
• Time to Cmax (Tmax) of ABBV-927
• Maximum observed serum concentration (Cmax) of ABBV-927
• Terminal-Phase Elimination Rate Constant (β) of ABBV-927
• Terminal half-life (t1/2) of ABBV-927
• Area under the serum concentration-time curve (AUCt) of ABBV-927
• Time to Cmax (Tmax) of ABBV-181
• Maximum observed serum concentration (Cmax) of ABBV-181
• Terminal-Phase Elimination Rate Constant (β) of ABBV-181
• Terminal half-life (t1/2) of ABBV-181
• Area under the serum concentration-time curve (AUCt) of ABBV-181
• Number of Participants with Adverse Events

• Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
• Duration of objective response (DOR)
• Objective response rate (ORR)
• Progression-free survival (PFS)

View this trial on ClinicalTrials.gov