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
A legfontosabb adatok
- Ki végzi
- AbbVie
- Hol
- Columbus, Duarte, Grand Rapids, Houston, Huntersville, Irvine, Los Angeles, New York, San Antonio és St Louis (Egyesült Államok)Mind a 11 helyszín megnézéseMég 2 másik országban, 7 helyszínen
- Azonosító
- Állapot
- Leállítva
- Fázis
- 1. fázis
- Résztvevők
- 27 fő vett részt
- Kezdés
- 2024. febr. 6.
- Befejezés
- 2025. okt. 22.
- A vizsgálat típusa
- Beavatkozással járó, 7 csoport
- A vizsgált kezelések
- ABBV-303
- Budigalimab
- A regiszteradat frissítve
- 2025. október 27.
- Miért állt le
- Strategic considerations
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 8 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- 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
Helyszínek itt: Egyesült Államok
Még 2 másik országban, 7 helyszínen
- The Ohio State University - The James /ID# 260475Columbus, Egyesült ÁllamokNo longer taking part
- City of Hope /ID# 254303Duarte, Egyesült ÁllamokNo longer taking part
- START Midwest /ID# 256945Grand Rapids, Egyesült ÁllamokNo longer taking part
- University of Texas MD Anderson Cancer Center /ID# 254308Houston, Egyesült ÁllamokNo longer taking part
- Carolina BioOncology Institute /ID# 254305Huntersville, Egyesült ÁllamokNo longer taking part
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792Irvine, Egyesült ÁllamokNo longer taking part
- University of Southern California /ID# 254356Los Angeles, Egyesült ÁllamokNo longer taking part
- NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943New York, Egyesült ÁllamokNo longer taking part
- NEXT Oncology /ID# 257395San Antonio, Egyesült ÁllamokNo longer taking part
- South Texas Accelerated Research Therapeutics /ID# 256944San Antonio, Egyesült ÁllamokNo longer taking part
- Washington University-School of Medicine /ID# 262943St Louis, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A teljes eredeti leírásKevesebb
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 vizsgálat 7 csoportja
- ABBV-303 Dose Escalation: Part 1A MonotherapyA vizsgált kezelés
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.
Kezelés: ABBV-303
- ABBV-303 Dose Expansion: Part 2A MonotherapyA vizsgált kezelés
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.
Kezelés: ABBV-303
- ABBV-303 Dose Expansion: Part 3A MonotherapyA vizsgált kezelés
Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Kezelés: ABBV-303
- ABBV-303 Dose Expansion: Part 4A MonotherapyA vizsgált kezelés
Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Kezelés: ABBV-303
- ABBV-303 Dose Expansion: Part 5A MonotherapyA vizsgált kezelés
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.
Kezelés: ABBV-303
- ABBV-303 Dose Escalation: Part 1B CombinationA vizsgált kezelés
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.
Kezelés: ABBV-303 és Budigalimab
- ABBV-303 Dose Expansion: Part 2B CombinationA vizsgált kezelés
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.
Kezelés: ABBV-303 és Budigalimab
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- 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 regiszteradat frissítve
- 2025. október 27.