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

Last updated: October 24, 2025
Sponsor: AbbVie
Overall Status: Terminated

Phase

1

Condition

Head And Neck Cancer

Solid Tumors

Neoplasms

Treatment

Budigalimab

ABBV-303

Clinical Study ID

NCT06158958
M24-122
2023-504714-30
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0or 1.

  • Laboratory values meeting the protocol's criteria within the screening period (-28days) prior to the first dose of study drug.

  • Participants with a diagnosis of a malignant solid tumor by histology (World HealthOrganization [WHO] criteria).

  • Participants with measurable disease per Response Evaluation Criteria in SolidTumors version 1.1 (RECIST v1.1).

Exclusion

Exclusion Criteria:

  • Unresolved Grade > 1 adverse events (AEs) from prior anti-cancer therapy except foralopecia.

  • Active systemic or uncontrolled local bacterial, fungal, or viral infectionrequiring antimicrobial therapy.

  • History of hypersensitivity to the active ingredients or any excipients of ABBV-303and budigalimab (ABBV-181).

  • Body weight < 35 kg.

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: Budigalimab
Phase: 1
Study Start date:
February 06, 2024
Estimated Completion Date:
October 22, 2025

Connect with a study center

  • Rambam Health Care Campus /ID# 254608

    Haifa, H_efa 3109601
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 259408

    Ramat Gan 293788, Tel Aviv 293396 5265601
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 259408

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • Hadassah Medical Center /ID# 254606

    Jerusalem, Yerushalayim 9112001
    Israel

    Active - Recruiting

  • Rambam Health Care Campus /ID# 254608

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 254606

    Jerusalem, 91120
    Israel

    Site Not Available

  • Hadassah Medical Center-Hebrew University /ID# 254606

    Jerusalem 281184, 91120
    Israel

    Site Not Available

  • National Cancer Center Hospital East /ID# 261712

    Kashiwa-shi, Chiba 2113014 277-8577
    Japan

    Site Not Available

  • Shizuoka Cancer Center /ID# 261714

    Sunto-gun, Shizuoka 1851715 411-8777
    Japan

    Site Not Available

  • National Cancer Center Hospital /ID# 254359

    Chuo-ku, Tokyo 1850144 104-0045
    Japan

    Site Not Available

  • Wakayama Medical University Hospital /ID# 254361

    Wakayama-shi, Wakayama 641-8510
    Japan

    Site Not Available

  • Wakayama Medical University Hospital /ID# 254361

    Wakayama 1926004, Wakayama 1848938 641-8510
    Japan

    Site Not Available

  • Wakayama Medical University Hospital /ID# 254361

    Wakayama, 641-0012
    Japan

    Site Not Available

  • City of Hope /ID# 254303

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792

    Irvine, California 92618
    United States

    Site Not Available

  • University of Southern California /ID# 254356

    Los Angeles, California 90033
    United States

    Site Not Available

  • City of Hope /ID# 254303

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792

    Irvine 5359777, California 5332921 92618
    United States

    Site Not Available

  • University of Southern California /ID# 254356

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • START Midwest /ID# 256945

    Grand Rapids, Michigan 49546-7062
    United States

    Site Not Available

  • START Midwest /ID# 256945

    Grand Rapids 4994358, Michigan 5001836 49546-7062
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 262943

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 262943

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 262943

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943

    New York, New York 10016-4744
    United States

    Site Not Available

  • NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Carolina BioOncology Institute /ID# 254305

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Carolina BioOncology Institute /ID# 254305

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Site Not Available

  • The Ohio State University - The James /ID# 260475

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • The Ohio State University - The James /ID# 260475

    Columbus 4509177, Ohio 5165418 43210-1240
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center /ID# 254308

    Houston, Texas 77030
    United States

    Site Not Available

  • NEXT Oncology /ID# 257395

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • South Texas Accelerated Research Therapeutics /ID# 256944

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center /ID# 254308

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • NEXT Oncology /ID# 257395

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • South Texas Accelerated Research Therapeutics /ID# 256944

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

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