A Phase 1 First-in Human, Multi-Center, 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 Tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508281-15-00

Acronym

M19-345

Enrollment

120

Registered

2024-03-05

Start date

2020-11-10

Completion date

Unknown

Last updated

2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Solid Tumors, Solid Tumors

Brief summary

Dose Escalation Phase: The determination of the RP2D of ABBV-151 as monotherapy and in combination with budigalimab, Dose Expansion Phase: Objective Response Rate of CR or PR

Detailed description

Dose Escalation Phase: Assessment of AEs, serious AEs (SAEs), laboratory parameters, vital signs, electrocardiogram (ECG) results, PK measurements, and antidrug antibody (ADA) measurements., Dose Expansion Phase: Duration of response (DOR), Dose Expansion Phase: Progression-free survival (PFS), Dose Expansion Phase: Assessment of AEs, SAEs, laboratory parameters, vital signs, ECG results, PK, and ADA measurements

Interventions

DRUGLivmoniplimab

DRUGBudigalimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose Escalation Phase: The determination of the RP2D of ABBV-151 as monotherapy and in combination with budigalimab, Dose Expansion Phase: Objective Response Rate of CR or PR	—

Secondary

Measure	Time frame
Dose Escalation Phase: Assessment of AEs, serious AEs (SAEs), laboratory parameters, vital signs, electrocardiogram (ECG) results, PK measurements, and antidrug antibody (ADA) measurements., Dose Expansion Phase: Duration of response (DOR), Dose Expansion Phase: Progression-free survival (PFS), Dose Expansion Phase: Assessment of AEs, SAEs, laboratory parameters, vital signs, ECG results, PK, and ADA measurements	—

Measure

Time frame

—

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026