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.

View Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT06158958

Recruitment Status:

Recruiting

Sponsor:

AbbVie

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There are 7 Locations for this study

See Locations Near You

START Midwest /ID# 256945
Grand Rapids Michigan, 49546, United States
Carolina BioOncology Institute /ID# 254305
Huntersville North Carolina, 28078, United States
University of Texas MD Anderson Cancer Center /ID# 254308
Houston Texas, 77030, United States
NEXT Oncology /ID# 257395
San Antonio Texas, 78229, United States
South Texas Accelerated Research Therapeutics /ID# 256944
San Antonio Texas, 78229, United States
Rambam Health Care Campus /ID# 254608
Haifa H_efa, 31096, Israel
The Chaim Sheba Medical Center /ID# 259408
Ramat Gan Tel-Aviv, 52656, Israel
Hadassah Medical Center /ID# 254606
Jerusalem Yerushalayim, 91120, Israel

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

192

Study ID:

NCT06158958

Recruitment Status:

Recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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