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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 27, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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).
- 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.