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

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
City of Hope /ID# 254303
RECRUITING
Duarte
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 266792
RECRUITING
Irvine
University of Southern California /ID# 254356
RECRUITING
Los Angeles
Michigan
START Midwest /ID# 256945
RECRUITING
Grand Rapids
Missouri
Washington University-School of Medicine /ID# 262943
COMPLETED
St Louis
North Carolina
Carolina BioOncology Institute /ID# 254305
RECRUITING
Huntersville
New York
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 256943
RECRUITING
New York
Ohio
The Ohio State University - The James /ID# 260475
RECRUITING
Columbus
Texas
University of Texas MD Anderson Cancer Center /ID# 254308
RECRUITING
Houston
NEXT Oncology /ID# 257395
RECRUITING
San Antonio
South Texas Accelerated Research Therapeutics /ID# 256944
RECRUITING
San Antonio
Other Locations
Israel
Rambam Health Care Campus /ID# 254608
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 254606
RECRUITING
Jerusalem
The Chaim Sheba Medical Center /ID# 259408
RECRUITING
Ramat Gan
Japan
National Cancer Center Hospital /ID# 254359
RECRUITING
Chuo-ku
National Cancer Center Hospital East /ID# 261712
RECRUITING
Kashiwa-shi
Shizuoka Cancer Center /ID# 261714
RECRUITING
Sunto-gun
Wakayama Medical University Hospital /ID# 254361
RECRUITING
Wakayama
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-02-06
Estimated Completion Date: 2028-01
Participants
Target number of participants: 192
Treatments
Experimental: ABBV-303 Dose Escalation: Part 1A Monotherapy
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.
Experimental: ABBV-303 Dose Expansion: Part 2A Monotherapy
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.
Experimental: ABBV-303 Dose Expansion: Part 3A Monotherapy
Participants with R/R RCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Experimental: ABBV-303 Dose Expansion: Part 4A Monotherapy
Participants with R/R HNSCC will receive ABBV-303 at the RP1ED as a monotherapy as part of the 3 year study duration.
Experimental: ABBV-303 Dose Expansion: Part 5A Monotherapy
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.
Experimental: ABBV-303 Dose Escalation: Part 1B Combination
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.
Experimental: ABBV-303 Dose Expansion: Part 2B Combination
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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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