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NCT06158958 | RECRUITING | 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
Sponsor:

AbbVie

Brief 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.

Condition or disease

Solid Tumors

Intervention/treatment

ABBV-303

Budigalimab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 192 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-02-06
Estimated Primary Completion Date : 2028-01-20
Estimated Study Completion Date : 2028-01-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06158958

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope /ID# 254303

Duarte, California, United States, 91010

RECRUITING

United States, California

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

Irvine, California, United States, 92618

RECRUITING

United States, California

University of Southern California /ID# 254356

Los Angeles, California, United States, 90033

RECRUITING

United States, Road cancer

START Midwest /ID# 256945

Grand Rapids, Road cancer, United States, 49546-7062

RECRUITING

United States, Missouri

Washington University-School of Medicine /ID# 262943

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, New York

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

New York, New York, United States, 10016-4744

RECRUITING

United States, North Carolina

Carolina BioOncology Institute /ID# 254305

Huntersville, North Carolina, United States, 28078

RECRUITING

United States, Ohio

The Ohio State University - The James /ID# 260475

Columbus, Ohio, United States, 43210-1240

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center /ID# 254308

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

NEXT Oncology /ID# 257395

San Antonio, Texas, United States, 78229

RECRUITING

United States, Texas

South Texas Accelerated Research Therapeutics /ID# 256944

San Antonio, Texas, United States, 78229

RECRUITING

Israel, H_EFA

Rambam Health Care Campus /ID# 254608

Haifa, H_efa, Israel, 3109601

RECRUITING

Israel, Tel-Aviv

The Chaim Sheba Medical Center /ID# 259408

Ramat Gain, Tel-Aviv, Israel, 5265601

RECRUITING

Israel,

Hadassah Medical Center-Hebrew University /ID# 254606

Jerusalem, Israel, 91120

RECRUITING

Japan, Chiba

National Cancer Center Hospital East /ID# 261712

Mr. Kashiwa, Chiba, Japan, 277-8577

RECRUITING

Japan, Shizuoka

Shizuoka Cancer Center /ID# 261714

Summary-gun, Shizuoka, Japan, 411-8777

RECRUITING

Japan, Tokyo

National Cancer Center Hospital /ID# 254359

C-Cry, Tokyo, Japan, 104-0045

RECRUITING

Japan,

Wakayama Medical University Hospital /ID# 254361

Wakayama, Japan, 641-0012