Moffitt Cancer Center: Clinical Trial 20851

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Clinical Trial 20851

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

Phase: Phase I
Prinicipal Investigator: Heather Han

Call 813-745-6100
or 1-800-679-0775 Learn More

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

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.