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NCT06158958Not yet recruiting

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

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
AbbViePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Solid Tumors
Drug/Device/Intervention
ABBV-303
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AbbVie
Timeline & enrollment
Phase
Phase 1
Start date
Feb 29, 2024
End date
Jan 20, 2028
Enrollment
181 participants
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
Malignant neoplasm: Connective and soft tissue, unspecifiedMalignant neoplasm of other connective and soft tissueCarcinoma in situ, unspecifiedMalignant neoplasmsMalignant neoplasm: Parametrium
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06158958
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.