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NCT03893955Active, not recruitingPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
150 (estimated)
First submitted
27 Mar 2019
Start date
21 May 2019
Primary completion date
Mar 2027
Lead sponsor
AbbVie
NCT number
NCT03893955
EudraCT number
2019-000478-45

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 150
  • From 21 May 2019 to the primary completion date, Mar 2027
  • 26 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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:
  • treatment of the toxicity with systemic corticosteroids

Other illness

  • Has history of inflammatory bowel disease or pneumonitis.
  • any hypersensitivity to the PD-1 or PD-L1-targeting agent

Other

  • Has uncontrolled metastases to the central nervous system.
  • any immune-mediated toxicity of Grade 3 or worse severity
  • any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duplicate_Icon Cancer Centre /ID# 224084
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South BrisbaneAustraliaUnknown status
Hospital Universitario Vall de Hebron /ID# 212804
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BarcelonaSpainUnknown status
Hospital Universitario Fundacion Jimenez Diaz /ID# 212806
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MadridSpainUnknown status
Hospital Universitario HM Sanchinarro /ID# 212805
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MadridSpainUnknown status
Hospital Universitario Virgen de la Victoria /ID# 221671
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MálagaSpainUnknown status
Centre Jean Perrin /ID# 217911
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Clermont-FerrandFranceUnknown status
Centre Leon Berard /ID# 217910
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LyonFranceUnknown status
Institut Curie /ID# 223475
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ParisFranceUnknown status
AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869
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ParisFranceUnknown status
Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880
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Saint-HerblainFranceUnknown status
The Chaim Sheba Medical Center /ID# 211699
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Ramat GanIsraelUnknown status
China Medical University Hospital /ID# 221090
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TaichungTaiwanUnknown status
National Taiwan University Hospital /ID# 210993
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TaipeiTaiwanUnknown status
Mary Crowley Cancer Research /ID# 210716
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DallasUnited StatesUnknown status
Duplicate_Duke Cancer Center /ID# 217641
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DurhamUnited StatesUnknown status
Virginia Cancer Specialists - Fairfax /ID# 210671
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FairfaxUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072
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Fort WayneUnited StatesUnknown status
Carolina BioOncology Institute /ID# 210664
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HuntersvilleUnited StatesUnknown status
Tennessee Oncology-Nashville Centennial /ID# 221400
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NashvilleUnited StatesUnknown status
Yale University School of Medicine /ID# 210678
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New HavenUnited StatesUnknown status
UPMC Hillman Cancer Ctr /ID# 222747
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PittsburghUnited StatesUnknown status
NEXT Oncology /ID# 210717
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San AntonioUnited StatesUnknown status
St Jude Hospital dba St Joseph /ID# 211130
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Santa RosaUnited StatesUnknown status
Highlands Oncology Group, PA /ID# 218863
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SpringdaleUnited StatesUnknown status
Washington University-School of Medicine /ID# 221399
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St LouisUnited StatesUnknown status
Moffitt Cancer Center /ID# 215037
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.