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
Public ClinicalTrials.gov record NCT06158958. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 First-in-Human, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABBV-303, as Monotherapy and in Combination With Budigalimab (ABBV-181), in Adult Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06158958
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2024
- Primary completion
- Oct 21, 2025
- Completion
- Oct 21, 2025
- Last update posted
- Oct 26, 2025
2024 – 2025
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope /ID# 254303 | Duarte | California | 91010 | — |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792 | Irvine | California | 92618 | — |
| University of Southern California /ID# 254356 | Los Angeles | California | 90033 | — |
| START Midwest /ID# 256945 | Grand Rapids | Michigan | 49546-7062 | — |
| Washington University-School of Medicine /ID# 262943 | St Louis | Missouri | 63110 | — |
| NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943 | New York | New York | 10016 | — |
| Carolina BioOncology Institute /ID# 254305 | Huntersville | North Carolina | 28078 | — |
| The Ohio State University - The James /ID# 260475 | Columbus | Ohio | 43210-1240 | — |
| University of Texas MD Anderson Cancer Center /ID# 254308 | Houston | Texas | 77030 | — |
| NEXT Oncology /ID# 257395 | San Antonio | Texas | 78229 | — |
| South Texas Accelerated Research Therapeutics /ID# 256944 | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06158958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2025 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06158958 live on ClinicalTrials.gov.