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
- Diseases
- Triple-negative breast cancer, Lung cancer
- 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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duplicate_Icon Cancer Centre /ID# 224084 Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Hospital Universitario Vall de Hebron /ID# 212804 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 212806 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario HM Sanchinarro /ID# 212805 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria /ID# 221671 Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Centre Jean Perrin /ID# 217911 Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Centre Leon Berard /ID# 217910 Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Institut Curie /ID# 223475 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| AP-HP - Hopital Bichat - Claude-Bernard /ID# 212869 Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Institut de Cancérologie de l'Ouest René Gauducheau /ID# 212880 Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| The Chaim Sheba Medical Center /ID# 211699 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| China Medical University Hospital /ID# 221090 Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital /ID# 210993 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Mary Crowley Cancer Research /ID# 210716 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duplicate_Duke Cancer Center /ID# 217641 Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Virginia Cancer Specialists - Fairfax /ID# 210671 Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Fort Wayne Medical Oncology and Hematology, Inc /ID# 226072 Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Carolina BioOncology Institute /ID# 210664 Coordinator of this site? Confirm its status | Huntersville | United States | Unknown status |
| Tennessee Oncology-Nashville Centennial /ID# 221400 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School of Medicine /ID# 210678 Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| UPMC Hillman Cancer Ctr /ID# 222747 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| NEXT Oncology /ID# 210717 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| St Jude Hospital dba St Joseph /ID# 211130 Coordinator of this site? Confirm its status | Santa Rosa | United States | Unknown status |
| Highlands Oncology Group, PA /ID# 218863 Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Washington University-School of Medicine /ID# 221399 Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt Cancer Center /ID# 215037 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.