Clinical trial NCT06158958: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Keywords: Solid Tumors
Non-Small Cell Lung Cancer
NSCLC
Renal Cell Carcinoma
RCC
Head and Neck Squamous Cell Carcinoma
HNSCC
ABBV-303
ABBV-181
Budigalimab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AE)
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: Up to 3 Years
measure: Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1
timeFrame: Up to 3 Years
measure: Progression-free survival (PFS)
timeFrame: Up to 3 Years
measure: Overall survival (OS)
timeFrame: Up to 3 Years
measure: ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST)
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope /ID# 254303
state: California
city: Irvine
country: United States
facility: City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792
state: California
city: Los Angeles
country: United States
facility: University of Southern California /ID# 254356
state: California
city: Grand Rapids
country: United States
facility: START Midwest /ID# 256945
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 262943
state: Missouri
city: New York
country: United States
facility: NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943
state: New York
city: Huntersville
country: United States
facility: Carolina BioOncology Institute /ID# 254305
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University - The James /ID# 260475
state: Ohio
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center /ID# 254308
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology /ID# 257395
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics /ID# 256944
state: Texas
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 254608
state: H_efa
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 259408
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 254606
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East /ID# 261712
state: Chiba
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 261714
state: Shizuoka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 254359
state: Tokyo
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital /ID# 254361
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: