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ACTIVE NOT RECRUITING
NCT03893955
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

ABBV-927

Intravenous (IV) Infusion

DRUG

ABBV-368

Intravenous (IV) Infusion

DRUG

ABBV-181

Intravenous (IV) Infusion

DRUG

Carboplatin

Intravenous (IV) Infusion

DRUG

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