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 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.
Checked against the public recordLast updated Aug 12, 2025 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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. Exclusion 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.
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
- 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: Aug 12, 2025. Always confirm current availability with the study team.