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Active Not RecruitingPhase 1NCT03893955
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedABBV-927 and ABBV-368

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 2, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?26 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AbbVie
Interventions being studied
Drug: ABBV-927; Drug: ABBV-368; Drug: ABBV-181; Drug: Carboplatin; Drug: Nab-paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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.
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Highlands Oncology Group, PA /ID# 218863Springdale, Arkansas
  • St Jude Hospital dba St Joseph /ID# 211130Santa Rosa, California
  • Yale University School of Medicine /ID# 210678New Haven, Connecticut
  • Moffitt Cancer Center /ID# 215037Tampa, Florida
  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072Fort Wayne, Indiana
  • Washington University-School of Medicine /ID# 221399St Louis, Missouri
  • Duplicate_Duke Cancer Center /ID# 217641Durham, North Carolina
  • Carolina BioOncology Institute /ID# 210664Huntersville, North Carolina
  • UPMC Hillman Cancer Ctr /ID# 222747Pittsburgh, Pennsylvania
  • Tennessee Oncology-Nashville Centennial /ID# 221400Nashville, Tennessee
  • Mary Crowley Cancer Research /ID# 210716Dallas, Texas
  • NEXT Oncology /ID# 210717San Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 2, 2026. Always confirm current availability with the study team.

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