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

Running, not enrolling · Phase 1

Conditions studied: Cancer, Advanced Solid Tumors, Triple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), Metastatic Solid Tumors

In brief

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.

Key facts

Study ID

NCT03893955

Run by

AbbVie

People needed

150

Starts

2019-05-21

Expected to finish

2026-03-01

Last updated by the study team

2025-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol.
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Dose-Escalation:
• Arm A: Participants with an advanced solid tumor who have progressed on standard therapies known to provide clinical benefit and/or participants who have refused or are intolerant of such therapy.
• Arm B (non-small-cell-lung-cancer [NSCLC]): Participants with histologically or cytologically confirmed NSCLC who previously progressed during or after an anti-programmed cell death (PD)-1 or PD ligand 1 (PD-L1) therapy and a platinum-based regimen in the recurrent or metastatic setting.
• Dose-Expansion:
• Arm 1, 2, and 3 (triple-negative breast cancer [TNBC]): Participants with histologically or cytologically confirmed breast adenocarcinoma that is estrogen receptor/progesterone receptor/human epidermal growth factor receptor (HER)2-negative who must have disease progression during or after at least 1 systemic therapy that included a taxane in the metastatic or recurrent setting and who are treatment-naïve to immunotherapy.
• Arm 4 (TNBC): Participants with histologically or cytologically confirmed TNBC who have received no previous anti-cancer therapy for TNBC, and who are PD-L1 negative on tumor tissue by immunohistochemistry (IHC) assay.
• Arm 5 (NSCLC): Participants with histologically or cytologically confirmed NSCLC who previously progressed either during or after an anti-PD-1 or PD-L1 therapy and a platinum-based regimen in the recurrent or metastatic setting.

You may not qualify if…

• Has history of inflammatory bowel disease or pneumonitis.
• Has uncontrolled metastases to the central nervous system.
• Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable.
• Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed.
• Has previously treated with an anti-PD- or PD-L1-targeting agent and had during the course of their therapy:
• any immune-mediated toxicity of Grade 3 or worse severity
• treatment of the toxicity with systemic corticosteroids
• any hypersensitivity to the PD-1 or PD-L1-targeting agent
• any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent

Where it is running

• 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

Full record on ClinicalTrials.gov

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