Clinical Trials /

A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors

NCT02955251

Description:

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

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

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating Safety and Pharmacokinetics, and the Recommended Phase 2 Dose (RPTD) of ABBV-428 in Participants With Advanced Solid Tumors
  • Official Title: A Multi-Center, Phase 1, Open-Label, Dose-Escalation Study of ABBV-428, an Immunotherapy in Subjects With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: M15-819
  • NCT ID: NCT02955251

Conditions

  • Advance Solid Tumors

Interventions

DrugSynonymsArms
ABBV-428Arm 1
NivolumabOPDIVOArm 2

Purpose

This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle).
  • ABBV-428
Arm 2ExperimentalABBV-428 plus nivolumab.
  • ABBV-428
  • Nivolumab
Arm A, B, and CExperimentalAdditional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428.
  • ABBV-428
Arm DExperimentalAdditional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab.
  • ABBV-428
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          -  Participants 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 have adequate bone marrow, renal, hepatic and coagulation function.

          -  For all dose expansion arms, participants must have measurable disease per Response
             Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

          -  Participants in combination therapy cohorts must have an advanced solid tumor where
             the use of nivolumab is standard therapy.

        Exclusion Criteria:

          -  Active or prior documented autoimmune disease in the last 2 years. Participants with
             childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave's disease,
             or psoriasis not requiring systemic treatment (within the past 2 years) are not
             excluded.

          -  Current or prior use of immunosuppressive medication within 14 days prior to the
             first dose (with certain exceptions).

          -  History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic
             leukemia, solid organ transplantation, or previous clinical diagnosis of
             tuberculosis.

          -  Confirmed positive test results for human immunodeficiency virus (HIV), or
             participants with chronic or active hepatitis B or C. Participants who have a history
             of hepatitis B or C who have documented cures after antiviral therapy may be
             enrolled.

          -  Prior grade greater than or equal to 3 immune-mediated neurotoxicity or pneumonitis
             (or any other unresolved or symptomatic adverse event in the last 3 months) while
             receiving immunotherapy.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:First dose of study drug through at least 100 days after end of treatment; up to 2 years after last participants first dose
Safety Issue:
Description:The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Up to 30 days after a 24-month of treatment period
Safety Issue:
Description:ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
Measure:Duration of Objective Response (DOR)
Time Frame:Up to 30 days after a 24-month of treatment period
Safety Issue:
Description:DOR defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Measure:Progression-Free Survival (PFS)
Time Frame:Up to 30 days after a 24-month of treatment period
Safety Issue:
Description:PFS time is defined as the time from the first dose of ABBV-428 to disease progression or death, whichever occurs first
Measure:Clinical benefit rate (CBR)
Time Frame:Up to 30 days after a 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.

Details

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

Trial Keywords

  • Non-squamous NSCLC
  • Advanced solid tumor
  • Ovarian cancer
  • Non-small cell lung cancer (NSCLC)
  • Cancer
  • Neoplasm
  • Nivolumab

Last Updated

April 7, 2017