A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
NCT03893955 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-08-12
Summary
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Conditions
- Cancer
- Advanced Solid Tumors
- Triple-Negative Breast Cancer (TNBC)
- Non-small-cell-lung-cancer (NSCLC)
- Metastatic Solid Tumors
Interventions
- DRUG
-
ABBV-927
Intravenous (IV) Infusion
- DRUG
-
ABBV-368
Intravenous (IV) Infusion
- DRUG
-
ABBV-181
Intravenous (IV) Infusion
- DRUG
-
Intravenous (IV) Infusion
- DRUG
-
Intravenous (IV) Infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
ABBVIE INC. · AbbVie
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-21
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Israel
- Spain
- Taiwan
Study Locations
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