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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

NCT03893955

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: M19-037
  • SECONDARY ID: 2019-000478-45
  • NCT ID: NCT03893955

Conditions

  • Cancer
  • Advanced Solid Tumors
  • Triple-Negative Breast Cancer (TNBC)
  • Non-small-cell-lung-cancer (NSCLC)
  • Metastatic Solid Tumors

Interventions

DrugSynonymsArms
ABBV-927Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
ABBV-368Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid Tumors
ABBV-181BudigalimabDose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLC
CarboplatinDose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBC
Nab-paclitaxelDose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBC

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation Arm A: ABBV-927 + ABBV-368 Solid TumorsExperimentalParticipants with Solid Tumors will receive various doses of ABBV-927 by intravenous (IV) infusion plus ABBV-368. This will determine the recommended phase two dose (RP2D) of ABBV-927.
  • ABBV-927
  • ABBV-368
Dose Escalation Arm B: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimentalParticipants with non-small-cell-lung-cancer (NSCLC) will receive ABBV-927 IV at various dose levels + ABBV-368 + ABBV-181. This will determine the recommended phase two dose (RP2D) of ABBV-927 + ABBV-368 + ABBV-181.
  • ABBV-927
  • ABBV-368
  • ABBV-181
Dose Expansion Arm 1: ABBV-927 + Carboplatin + ABBV-368 TNBCExperimentalParticipants with Triple Negative Breast Cancer (TNBC) will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-368 by IV.
  • ABBV-927
  • ABBV-368
  • Carboplatin
Dose Expansion Arm 2: ABBV-927 + Carboplatin + ABBV-181 TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin + ABBV-181 by IV.
  • ABBV-927
  • ABBV-181
  • Carboplatin
Dose Expansion Arm 3: ABBV-927 + Carboplatin TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Carboplatin by IV.
  • ABBV-927
  • Carboplatin
Dose Expansion Arm 4: ABBV-927+ Nab-paclitaxel + ABBV-368 TNBCExperimentalParticipants with TNBC will receive ABBV-927 (at the RP2D established in Arm A) + Nab-paclitaxel + ABBV-368 by IV.
  • ABBV-927
  • ABBV-368
  • Nab-paclitaxel
Dose Expansion Arm 5: ABBV-927 + ABBV-368 + ABBV-181 NSCLCExperimentalParticipants with NSCLC will receive ABBV-927 (at the RP2D established in Arm B) + ABBV-368 + ABBV-181 by IV.
  • ABBV-927
  • ABBV-368
  • ABBV-181

Eligibility 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:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Expansion: Objective Response Rate (ORR)
Time Frame:Up to approximately 2 years following the first dose of study drug
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Dose-Expansion Phase: Progression-free Survival (PFS)
Time Frame:Up to approximately 2 years since the first dose of study drug
Safety Issue:
Description:PFS is defined as the time from date of first study drug exposure to disease progression or death, whichever occurs first.
Measure:Dose-Expansion Phase: Duration of Response (DOR)
Time Frame:Up to approximately 2 years since the first dose of study drug
Safety Issue:
Description:DOR defined as the time from the participant's initial response to study drug therapy to disease progression or death, whichever occurs first.
Measure:Maximum Serum Concentration (Cmax)
Time Frame:Up to approximately 12 weeks after participant's initial dose of study drug
Safety Issue:
Description:Maximum Serum Concentration (Cmax)
Measure:Time to Maximum Observed Serum Concentration (Tmax)
Time Frame:Up to approximately 12 weeks after participant's initial dose of study drug
Safety Issue:
Description:Time to Maximum Observed Serum Concentration (Tmax)
Measure: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
Safety Issue:
Description:Area under the serum concentration versus time curve from time 0 to the time of the last measurable concentration (AUCτ).
Measure:Terminal Phase Elimination Half-life (t1/2)
Time Frame:Up to approximately 4 weeks after participant's initial dose of study drug
Safety Issue:
Description:Terminal Phase Elimination Half-life (t1/2)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Advanced Solid Tumors
  • Triple-Negative Breast Cancer (TNBC)
  • Non-small-cell-lung-cancer (NSCLC)
  • ABBV-927
  • ABBV-368
  • ABBV-181
  • metastatic solid tumors
  • dose-escalation
  • recommended phase 2 dose
  • budigalimab

Last Updated

March 9, 2020