Clinical Trials /

A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Participants With Advanced Solid Tumors

NCT02988960

Description:

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors
  • Official Title: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927 and ABBV-181, an Immunotherapy, in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: M15-862
  • SECONDARY ID: 2016-002219-16
  • NCT ID: NCT02988960

Conditions

  • Advanced Solid Tumors Cancer

Interventions

DrugSynonymsArms
ABBV-927Escalating Arm 1
ABBV-927Escalation Arm 4
ABBV-181Expansion Arm B

Purpose

This is a dose-escalation study designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of ABBV-927, and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Expansion Arm CExperimentalAdditional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-927 plus ABBV-181.
  • ABBV-927
  • ABBV-181
Expansion Arm AExperimentalAdditional participants (with Head and Neck Squamous Cell Carcinoma (HNSCC), or non-small cell lung cancer [NSCLC]) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927.
  • ABBV-927
Escalating Arm 2ExperimentalABBV-927 via intratumoral administration at escalating dose levels in 28-day dosing cycles (initially 2 doses per cycle).
  • ABBV-927
Escalating Arm 1ExperimentalABBV-927 via intravenous administration at escalating dose levels in 28-day dosing cycles (initially 2 doses per cycle).
  • ABBV-927
Expansion Arm BExperimentalAdditional participants (with HNSCC) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-927 plus ABBV-181.
  • ABBV-927
  • ABBV-181
Escalation Arm 3ExperimentalABBV-927 via intravenous administration at escalating dose levels (initially 2 doses per cycle) in combination with ABBV-181 via intravenous administration.
  • ABBV-927
  • ABBV-181
Escalation Arm 4ExperimentalABBV-927 via intratumoral administration at escalating dose levels (initially 2 doses per cycle) in combination with ABBV-181 via intravenous administration.
  • ABBV-927
  • ABBV-181

Eligibility Criteria

        Inclusion Criteria:

          -  Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
             to 1.

          -  Participants have adequate bone marrow, kidney and liver function.

          -  Participants with a history of chronic heart failure or significant cardiovascular
             disease must have an echocardiogram or multigated acquisition scan indicating left
             ventricular ejection fraction greater than or equal to 45% within 28 days prior to the
             first dose of study drug.

          -  Participants must have creatinine clearance greater than or equal to 50 mL/min as
             measured by 24-hour urine or estimated by the Cockcroft-Gault formula.

          -  Participants must have total bilirubin less than or equal to 1.5 times the upper limit
             of normal (ULN), and aspartate aminotransferase and alanine aminotransferase less than
             or equal to 2.5 times ULN.

          -  Participants in all monotherapy arms must have an advanced solid tumor that has
             progressed on standard therapies known to provide clinical benefit or the participants
             are intolerant to such therapies.

          -  Participants in all combination therapy arms must have recurrent or metastatic NSCLC
             and previously received platinum-based therapy and progressed either during or after
             anti-programmed death ligand 1 (PDL1)-based therapy. In addition, participants must
             have received only one prior immunotherapy.

          -  The Sponsor may decide to limit the specific tumor types selected or treatment
             settings for specific arms based on evidence gathered.

        Exclusion Criteria:

          -  Participant must not have an active or prior documented autoimmune disease in the last
             2 years.

          -  Participant must not have current or prior use of immunosuppressive medication within
             14 days prior to the first dose (with certain exceptions).

          -  Participant must not have a history of primary immunodeficiency, bone marrow
             transplantation, chronic lymphocytic leukemia, solid organ transplantation, previous
             clinical diagnosis of tuberculosis, inflammatory bowel disease, interstitial lung
             disease, or immune-mediated pneumonitis.

          -  Participant must not have a history of a coagulopathy or a platelet disorder.

          -  Participant must not have a prior grade greater than or equal to 3 immune-mediated
             neurotoxicity or pneumonitis while receiving immunotherapy.

          -  Participant must not have a known uncontrolled malignancy of the central nervous
             system.

          -  Participants in all combination therapy arms must not have a history of exposure to an
             immunotherapy experiencing an immune-mediated adverse event that required permanent
             discontinuation of the immunotherapy.

          -  Female participants must not be pregnant, breastfeeding or considering becoming
             pregnant during the study or for at least 3 or 5 months (for monotherapy and
             combination therapy participants, respectively) after the last dose of study drug.

          -  Male participants must not be considering fathering a child or donating sperm during
             the study or for at least 3 or 5 months (for monotherapy and combination therapy
             participants, respectively) after the last dose of study drug.

          -  Participant is judged by the investigator to have evidence of hemolysis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD) or recommended Phase 2 dose (RPTD) for ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181
Time Frame:Up to 8 weeks
Safety Issue:
Description:The MTD and the RPTD of ABBV-927 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study. Once the RPTD has been determined, the dose expansion portion will begin.

Secondary Outcome Measures

Measure:Clinical benefit rate (CBR, defined as the percentage of participants with a confirmed partial, complete response, or stable disease for at least 24 weeks to the treatment)
Time Frame:Up to 30 days after and up to 24-month of treatment period
Safety Issue:
Description:CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease for at least 24 weeks to the treatment.
Measure:Duration of objective response (DOR)
Time Frame:Up to 30 days after and up to 24-month of treatment period
Safety Issue:
Description:DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measure:Objective response rate (ORR)
Time Frame:Up to 30 days after and up to 24-month of treatment period
Safety Issue:
Description:ORR is defined as the proportion of participants with a confirmed partial or complete response to the treatment
Measure:Progression-free survival (PFS)
Time Frame:Up to 30 days after and up to 24-month of treatment period
Safety Issue:
Description:PFS time is defined as the time from the first dose of ABBV-927 to disease progression or death, whichever occurs first.

Details

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

Trial Keywords

  • Non-small cell lung cancer (NSCLC)
  • Squamous cell carcinoma of the head and neck (SCCHN)
  • Advanced solid tumor
  • Cancer
  • Pancreatic adenocarcinoma
  • Cutaneous melanoma

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