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
NCT ID: NCT06158958
Last Updated: 2025-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
27 participants
INTERVENTIONAL
2024-02-06
2025-10-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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ABBV-303 Dose Escalation: Part 1A Monotherapy
Participants with (R)/refractory (R) solid tumors will receive ABBV-303 in escalating doses as a monotherapy until the maximum tolerable dose (MTD) is determined as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
ABBV-303 Dose Expansion: Part 2A Monotherapy
Participants with R/R NSCLC will receive ABBV-303 at the recommended phase 1 expansion dose (RP1ED) as a monotherapy as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
ABBV-303 Dose Expansion: Part 3A Monotherapy
Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
ABBV-303 Dose Expansion: Part 4A Monotherapy
Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
ABBV-303 Dose Expansion: Part 5A Monotherapy
Tissue agnostic with R/R participants with MET amplification by any commercially available test will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
ABBV-303 Dose Escalation: Part 1B Combination
Participants with R/R solid tumors will receive ABBV-303 in combination with budigalimab at or below the MTD as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
Budigalimab
IV Infusion
ABBV-303 Dose Expansion: Part 2B Combination
Participants with R/R NSCLC will receive ABBV-303 at or below the MTD in combination with budigalimab as part of the 3 year study duration.
ABBV-303
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Interventions
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ABBV-303
Intravenous (IV) Infusion
Budigalimab
IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Related Links
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Other Identifiers
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2023-504714-30
Identifier Type: OTHER
Identifier Source: secondary_id
M24-122
Identifier Type: -
Identifier Source: org_study_id
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