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A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor: AbbVie
Summary
A study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of ABBV-927 with ABBV-368, Budigalimab (ABBV-181) and/or chemotherapy in participants with selected solid tumors. This study consists of 2 main parts, a dose-escalation phase and a dose-expansion phase. The dose-expansion phase can begin once the recommended phase 2 dose/maximum tolerated dose (RP2D/MTD) is determined in the dose-escalation phase.
Official title: A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Combinations of ABBV-927 With ABBV-368, Budigalimab (ABBV-181) and/or Chemotherapy in Subjects With Locally Advanced or Metastatic Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2019-05-21
Completion Date
2026-03
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
ABBV-927
Intravenous (IV) Infusion
ABBV-368
Intravenous (IV) Infusion
ABBV-181
Intravenous (IV) Infusion
Carboplatin
Intravenous (IV) Infusion
Nab-paclitaxel
Intravenous (IV) Infusion
Locations (26)
Highlands Oncology Group, PA /ID# 218863
Springdale, Arkansas, United States
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa, California, United States
Yale University School of Medicine /ID# 210678
New Haven, Connecticut, United States
Moffitt Cancer Center /ID# 215037
Tampa, Florida, United States
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
Fort Wayne, Indiana, United States
Washington University-School of Medicine /ID# 221399
St Louis, Missouri, United States
Duke Cancer Center /ID# 217641
Durham, North Carolina, United States
Carolina BioOncology Institute /ID# 210664
Huntersville, North Carolina, United States
UPMC Hillman Cancer Ctr /ID# 222747
Pittsburgh, Pennsylvania, United States
Tennessee Oncology-Nashville Centennial /ID# 221400
Nashville, Tennessee, United States
Mary Crowley Cancer Research /ID# 210716
Dallas, Texas, United States
NEXT Oncology /ID# 210717
San Antonio, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 210671
Fairfax, Virginia, United States
Duplicate_Icon Cancer Centre /ID# 224084
South Brisbane, Queensland, Australia
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880
Saint-Herblain, Loire-Atlantique, France
Institut Curie /ID# 223475
Paris, Paris, France
Centre Leon Berard /ID# 217910
Lyon, Rhone, France
Centre Jean Perrin /ID# 217911
Clermont-Ferrand, France
AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869
Paris, France
The Chaim Sheba Medical Center /ID# 211699
Ramat Gan, Tel Aviv, Israel
Hospital Universitario Vall d'Hebron /ID# 212804
Barcelona, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806
Madrid, Spain
Hospital Universitario HM Sanchinarro /ID# 212805
Madrid, Spain
Hospital Universitario Virgen de la Victoria /ID# 221671
Málaga, Spain
National Taiwan University Hospital /ID# 210993
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 221090
Taichung, Taiwan