Study to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Participants With Locally Advanced or Metastatic Solid Tumours

Official Title

A Phase 1 First-in Human, Multi-Centre, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumours

Summary:

The study will determine the recommended Phase 2 dose (RP2D) of ABBV-151 administered as monotherapy and in combination with budigalimab (ABBV-181) as well as to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-151 alone and in combination with budigalimab. The study will consist of 2 phases: dose escalation and dose expansion.

Trial Description

Primary Outcome:

• Dose Escalation: Recommended Phase 2 Dose (RP2D) ABBV-151 Monotherapy
• Dose Escalation: RP2D ABBV-151 + Budigalimab Combination Therapy
• Dose Expansion: Objective Response Rate (ORR)

• Dose Expansion: Duration of Response (DOR)
• Dose Expansion: Progression-free Survival (PFS)
• Maximum Observed Serum Concentration (Cmax) of ABBV-151
• Time to Maximum Observed Serum Concentration (Tmax) of ABBV-151
• Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of ABBV-151
• Terminal-phase Elimination Rate Constant (β) of ABBV-151
• Terminal Phase Elimination Half-life (t1/2) of ABBV-151
• Maximum Observed Serum Concentration (Cmax) of Budigalimab
• Time to Maximum Observed Serum Concentration (Tmax) of Budigalimab
• Area Under the Plasma Concentration-time Curve over time from 0 to last measurable concentration (AUCτ) of Budigalimab
• Terminal-phase Elimination Rate Constant (β) of Budigalimab
• Terminal Phase Elimination Half-life (t1/2) of Budigalimab
• Number of Participants With Adverse Events (AEs)
• Change in Vital Signs
• Change in Laboratory Parameters
• Change in Electrocardiogram (ECG)
• Incidence of Anti-drug Antibody (ADA)

View this trial on ClinicalTrials.gov