Kidney Cancer Clinical Trial
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
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.
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There are 15 Locations for this study
Duarte California, 91010, United States
Irvine California, 92618, United States More Info
Los Angeles California, 90033, United States
Grand Rapids Michigan, 49546, United States
Saint Louis Missouri, 63110, United States
Huntersville North Carolina, 28078, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Haifa H_efa, 31096, Israel
Ramat Gan Tel-Aviv, 52656, Israel
Jerusalem , 91120, Israel
Kashiwa-shi Chiba, 277-8, Japan
Sunto-gun Shizuoka, 411-8, Japan
Chuo-ku Tokyo, 104-0, Japan
Wakayama-shi Wakayama, 641-8, Japan
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