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

  • End date
    Jul 6, 2024
  • participants needed
  • sponsor
Updated on 26 July 2022
systemic therapy
breast cancer
growth factor
treatment regimen
epidermal growth factor receptor
cancer treatment
primary cancer
cancer chemotherapy
solid tumour
solid tumor
progesterone receptor
epidermal growth factor
estrogen receptor
breast adenocarcinoma
solid neoplasm
advanced malignant solid tumor


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.

Condition Cancer, Advanced Solid Tumors, Triple-Negative Breast Cancer (TNBC), Non-small-cell-lung-cancer (NSCLC), Metastatic Solid Tumors
Treatment docetaxel, carboplatin, Nab-paclitaxel, ABBV-927, ABBV-181, ABBV-368
Clinical Study IdentifierNCT03893955
Last Modified on26 July 2022


Yes No Not Sure

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
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

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
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