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

Stopped early · Phase 1

Conditions studied: Solid Tumors

In brief

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.

Key facts

Study ID: NCT06158958
Run by: AbbVie
People needed: 27
Starts: 2024-02-06
Expected to finish: 2025-10-22
Last updated by the study team: 2025-10-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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.

Where it is running

City of Hope /ID# 254303 — Duarte, California, United States
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792 — Irvine, California, United States
University of Southern California /ID# 254356 — Los Angeles, California, United States
START Midwest /ID# 256945 — Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 262943 — St Louis, Missouri, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943 — New York, New York, United States
Carolina BioOncology Institute /ID# 254305 — Huntersville, North Carolina, United States
The Ohio State University - The James /ID# 260475 — Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center /ID# 254308 — Houston, Texas, United States
NEXT Oncology /ID# 257395 — San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 256944 — San Antonio, Texas, United States
The Chaim Sheba Medical Center /ID# 259408 — Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus /ID# 254608 — Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 254606 — Jerusalem, Israel
National Cancer Center Hospital East /ID# 261712 — Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center /ID# 261714 — Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 254359 — Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 254361 — Wakayama, Wakayama, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.