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

Description

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.

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope /ID# 254303, Duarte, California, United States, 91010

Irvine

City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792, Irvine, California, United States, 92618

Los Angeles

University of Southern California /ID# 254356, Los Angeles, California, United States, 90033

Grand Rapids

START Midwest /ID# 256945, Grand Rapids, Michigan, United States, 49546-7062

Saint Louis

Washington University-School of Medicine /ID# 262943, Saint Louis, Missouri, United States, 63110

New York

NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943, New York, New York, United States, 10016-4744

Huntersville

Carolina BioOncology Institute /ID# 254305, Huntersville, North Carolina, United States, 28078

Columbus

The Ohio State University - The James /ID# 260475, Columbus, Ohio, United States, 43210-1240

Houston

University of Texas MD Anderson Cancer Center /ID# 254308, Houston, Texas, United States, 77030

San Antonio

NEXT Oncology /ID# 257395, San Antonio, Texas, United States, 78229

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2028-01-20