A Study of Adverse Events, How Intravenously (IV) Infused ABBV-303 Moves Through the Body, and Change in Disease State, as Monotherapy and in Combination With IV Infused Budigalimab (ABBV-181), in Adult Participants With Advanced Solid Tumors - Trial NCT06158958
Access comprehensive clinical trial information for NCT06158958 through Pure Global AI's free database. This Phase 1 trial is sponsored by AbbVie and is currently Not yet recruiting. The study focuses on Solid Tumors. Target enrollment is 181 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 1
Feb 29, 2024
Jan 20, 2028
Primary Outcome
Percentage of Participants With Adverse Events (AE)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06158958
Non-Device Trial