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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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Adequate liver, kidney and hematology function as demonstrated by laboratory values detailed in the study protocol.
  2. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Dose-Escalation:
  3. 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.
  4. 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:
  5. 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.
  6. 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.
  7. 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

  1. Has history of inflammatory bowel disease or pneumonitis.
  2. Has uncontrolled metastases to the central nervous system.
  3. Has a concurrent malignancy that is clinically significant, treatment is required, or the participant is not clinically stable.
  4. Has had a major surgery ≤ 28 days prior to the first dose of study drug or the surgical wound is not fully healed.
  5. Has previously treated with an anti-PD
  6. or PD-L1-targeting agent and had during the course of their therapy:
  7. any immune-mediated toxicity of Grade 3 or worse severity
  8. treatment of the toxicity with systemic corticosteroids
  9. any hypersensitivity to the PD-1 or PD-L1-targeting agent
  10. any treatment-related toxicity resulting in discontinuation of the PD-1 or PD-L1 targeting agent
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 844-663-3742Email iconEmail Study Center

Study’s details


Contition

Advanced Solid Tumors,Cancer,Head and Neck Squamous Cell Carcinoma (HNSCC),Metastatic Solid Tumors,Non-small-cell-lung-cancer (NSCLC),Triple-Negative Breast Cancer (TNBC)

Age

18+

Phase

Phase 1

Participants needed

150

Est. Completion Date

Nov 2023

Treatment type

Interventional


Sponsor

AbbVie

ClinicalTrials.gov identifier

NCT03893955

Study number

M19-037

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