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
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 of ABBV-303 as a monotherapy and in combination with budigalimab, (ABBV-181). ABBV-303 is an investigational drug being developed for the treatment of solid tumors. There are multiple treatment arms in this study. Participants will either receive ABBV-303 as a single agent or in combination with budigalimab (another investigational drug) at different doses. Approximately 181 adult participants will be enrolled in the study across sites worldwide. In Part A, ABBV-303 will be intravenously (IV) infused in escalating doses as a monotherapy in participants with relapsed (R)/refractory (R) solid tumors, R/R non-small cell lung cancer (NSCLC), R/R renal cell carcinoma (RCC), R/R head and neck squamous cell carcinoma (HNSCC), or R/R tissue agnostic participants with mesenchymal epithelial transition. In Part B, ABBV-303 in combination with budigalimab will be IV infused in participants with R/R solid tumors or NSCLC. The estimated duration of the study is up to 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Checked against the public recordLast updated Oct 27, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AbbVie
- Interventions being studied
- Drug: ABBV-303; Drug: Budigalimab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- City of Hope /ID# 254303Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792Irvine, California
- University of Southern California /ID# 254356Los Angeles, California
- START Midwest /ID# 256945Grand Rapids, Michigan
- Washington University-School of Medicine /ID# 262943St Louis, Missouri
- NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943New York, New York
- Carolina BioOncology Institute /ID# 254305Huntersville, North Carolina
- The Ohio State University - The James /ID# 260475Columbus, Ohio
- University of Texas MD Anderson Cancer Center /ID# 254308Houston, Texas
- NEXT Oncology /ID# 257395San Antonio, Texas
- South Texas Accelerated Research Therapeutics /ID# 256944San Antonio, Texas
- The Chaim Sheba Medical Center /ID# 259408Ramat Gan, Tel Aviv
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 27, 2025. Always confirm current availability with the study team.