Status:
TERMINATED
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ABBV-303, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adults With Advanced Solid Tumors
Lead Sponsor:
AbbVie
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy o...
Eligibility Criteria
Inclusion
- Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Laboratory values meeting the protocol's criteria within the screening period (-28 days) prior to the first dose of study drug.
- Participants with a diagnosis of a malignant solid tumor by histology (World Health Organization \[WHO\] criteria).
- Participants with measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Exclusion
- Unresolved Grade \> 1 adverse events (AEs) from prior anti-cancer therapy except for alopecia.
- Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring antimicrobial therapy.
- History of hypersensitivity to the active ingredients or any excipients of ABBV-303 and budigalimab (ABBV-181).
- Body weight \< 35 kg.
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2025
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06158958
Start Date
February 6 2024
End Date
October 22 2025
Last Update
October 27 2025
Active Locations (18)
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1
City of Hope /ID# 254303
Duarte, California, United States, 91010
2
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792
Irvine, California, United States, 92618
3
University of Southern California /ID# 254356
Los Angeles, California, United States, 90033
4
START Midwest /ID# 256945
Grand Rapids, Michigan, United States, 49546-7062