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
- Registration Number
- NCT06158958
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ABBV-303 Dose Escalation: Part 1B Combination Budigalimab 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. ABBV-303 Dose Escalation: Part 1A Monotherapy ABBV-303 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. ABBV-303 Dose Expansion: Part 2A Monotherapy ABBV-303 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. ABBV-303 Dose Expansion: Part 3A Monotherapy ABBV-303 Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration. ABBV-303 Dose Expansion: Part 4A Monotherapy ABBV-303 Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration. ABBV-303 Dose Expansion: Part 5A Monotherapy ABBV-303 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. ABBV-303 Dose Escalation: Part 1B Combination ABBV-303 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. ABBV-303 Dose Expansion: Part 2B Combination Budigalimab 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. ABBV-303 Dose Expansion: Part 2B Combination ABBV-303 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AE) 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.
- Secondary Outcome Measures
Name Time Method ORR per Immune-Mediated Response Evaluation Criteria in Solid Tumors (iRECIST) 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.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 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.
Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 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.
Progression-free survival (PFS) 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.
Overall survival (OS) Up to 3 Years OS is defined as time from first study treatment to death due to any cause.
Related Research Topics
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Trial Locations
- Locations (18)
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943
🇺🇸New York, New York, United States
City of Hope /ID# 254303
🇺🇸Duarte, California, United States
City of Hope at Orange County Lennar Foundation Cancer Center /ID# 266792
🇺🇸Irvine, California, United States
University of Southern California /ID# 254356
🇺🇸Los Angeles, California, United States
START Midwest /ID# 256945
🇺🇸Grand Rapids, Michigan, United States
Washington University-School of Medicine /ID# 262943
🇺🇸Saint Louis, Missouri, United States
Carolina BioOncology Institute /ID# 254305
🇺🇸Huntersville, North Carolina, United States
The Ohio State University - The James /ID# 260475
🇺🇸Columbus, Ohio, United States
University of Texas MD Anderson Cancer Center /ID# 254308
🇺🇸Houston, Texas, United States
NEXT Oncology /ID# 257395
🇺🇸San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics /ID# 256944
🇺🇸San Antonio, Texas, United States
Rambam Health Care Campus /ID# 254608
🇮🇱Haifa, H_efa, Israel
The Chaim Sheba Medical Center /ID# 259408
🇮🇱Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 254606
🇮🇱Jerusalem, Israel
National Cancer Center Hospital East /ID# 261712
🇯🇵Kashiwa-shi, Chiba, Japan
Shizuoka Cancer Center /ID# 261714
🇯🇵Sunto-gun, Shizuoka, Japan
National Cancer Center Hospital /ID# 254359
🇯🇵Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 254361
🇯🇵Wakayama, Japan