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NCT Number: NCT03893955

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duplicate_Icon Cancer Centre /ID# 224084, South Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ABBV-927

Drug

Intravenous (IV) Infusion

ABBV-368

Drug

Intravenous (IV) Infusion

ABBV-181

Drug

Intravenous (IV) Infusion

Other names: Budigalimab

carboplatin

Drug

Intravenous (IV) Infusion

Nab-paclitaxel

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Dose Expansion: Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years following the first dose of study drug

    ORR is defined as the percentage of participants with either complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  2. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368

    Time frame: Up to approximately 6 months

    The RP2D of ABBV-927 + ABBV-368 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.

  3. Dose-Escalation Phase: Recommended Phase 2 Dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181

    Time frame: Up to approximately 6 months

    The RP2D of ABBV-927 + ABBV-368 + ABBV-181 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics data.

Secondary outcomes

  1. Dose-Expansion Phase: Progression-free Survival (PFS)

    Time frame: Up to approximately 2 years since the first dose of study drug

    PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.

  2. Dose-Expansion Phase: Duration of Response (DOR)

    Time frame: Up to approximately 2 years since the first dose of study drug

    DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.

  3. Maximum Serum Concentration (Cmax)

    Time frame: Up to approximately 12 weeks after participant's initial dose of study drug

    Maximum Serum Concentration (Cmax)

  4. Time to Maximum Observed Serum Concentration (Tmax)

    Time frame: Up to approximately 12 weeks after participant's initial dose of study drug

    Time to Maximum Observed Serum Concentration (Tmax)

  5. Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCτ)

    Time frame: Up to approximately 12 weeks after participant's initial dose of study drug

    Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).

  6. Terminal Phase Elimination Half-life (t1/2)

    Time frame: Up to approximately 4 weeks after participant's initial dose of study drug

    Terminal Phase Elimination Half-life (t1/2)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2019
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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