Breast Cancer Clinical Trial
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.
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.
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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 26 Locations for this study
Springdale Arkansas, 72762, United States
Santa Rosa California, 95403, United States
New Haven Connecticut, 06510, United States
Tampa Florida, 33612, United States
Fort Wayne Indiana, 46804, United States
Saint Louis Missouri, 63110, United States
Durham North Carolina, 27710, United States
Huntersville North Carolina, 28078, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
San Antonio Texas, 78229, United States
Fairfax Virginia, 22031, United States
South Brisbane Queensland, 4101, Australia
Paris CEDEX 05 Ile-de-France, 75248, France
St Herblain CEDEX Loire-Atlantique, 44805, France
Lyon CEDEX 08 Rhone, 69373, France
Clermont Ferrand , 63011, France
Paris , 75018, France
Ramat Gan Tel-Aviv, 52656, Israel
Barcelona , 08035, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Taichung City , 40447, Taiwan
Taipei City , 100, Taiwan
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.