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

October 24, 2025 updated by: AbbVie

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 254608
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center-Hebrew University /ID# 254606
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 259408
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East /ID# 261712
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center /ID# 261714
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital /ID# 254359
    • Wakayama
      • Wakayama, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 254361
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope /ID# 254303
      • Irvine, California, United States, 92618
        • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792
      • Los Angeles, California, United States, 90033
        • University of Southern California /ID# 254356
    • Michigan
      • Grand Rapids, Michigan, United States, 49546-7062
        • START Midwest /ID# 256945
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University-School of Medicine /ID# 262943
    • New York
      • New York, New York, United States, 10016
        • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute /ID# 254305
    • Ohio
      • Columbus, Ohio, United States, 43210-1240
        • The Ohio State University - The James /ID# 260475
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center /ID# 254308
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology /ID# 257395
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics /ID# 256944

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: ABBV-303
Intravenous (IV) Infusion
Experimental: 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.
Drug: Budigalimab
IV Infusion
Other Names:
  • ABBV-181
Drug: ABBV-303
Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AE)
Time Frame: Up to 3 Years
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Up to 3 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time Frame: Up to 3 Years
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to RECIST version 1.1.
Up to 3 Years
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
Time Frame: Up to 3 Years
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
Up to 3 Years
Progression-free survival (PFS)
Time Frame: Up to 3 Years
PFS is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
Up to 3 Years
Overall survival (OS)
Time Frame: Up to 3 Years
OS is defined as time from first study treatment to death due to any cause.
Up to 3 Years
ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)
Time Frame: Up to 3 Years
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to iRECIST version 1.1.
Up to 3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2024

Primary Completion (Actual)

October 22, 2025

Study Completion (Actual)

October 22, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 24, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M24-122
  • 2023-504714-30 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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