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Clinical Trial 20851

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03893955

Phase: Phase I
Prinicipal Investigator: Heather Han

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Overview

Study Title

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

Summary

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.

Objective

The primary objectives of this study are: Dose-Escalation Phase: To determine the recommended Phase 2 dose (RP2D) of ABBV-927 + ABBV-368 with and without budigalimab (ABBV-181). Dose-Expansion Phase: To determine the preliminary objective response rate (ORR; using Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) of combinations of ABBV-927 with ABBV-368, budigalimab (ABBV-181), and/or chemotherapy in selected tumor types.

Treatments

Therapies

Medications

ABBV-181 (Budigalimab); ABBV-368 (); ABBV-927 (); Budigalimab (); Nab-paclitaxel (Abraxane); Paraplatin (carboplatin); carboplatin ()

Inclusion Criteria

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. 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.

  • Exclusion Criteria

    Exclusion Criteria:

  • History of inflammatory bowel disease or pneumonitis.
  • Uncontrolled metastases to the central nervous system.
  • 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.
  • 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
  • Other exclusions may apply

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