Clareo Health | 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 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
