Clinical Trial: A Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Anti-Tumor Activity of ABBV-176 in Subjects With Advanced Solid Tumors Likely to Express Prolactin Receptor (PRLR)

Brief Summary: This is an open-label, Phase I, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-176 for participants with advanced solid tumors likely to express Prolactin Receptor (PRLR). The study will consist of 2 cohorts: Dose Escalation and Expanded Recommended Phase 2 Dose.

Detailed Summary:
Sponsor: AbbVie

Current Primary Outcome:

  • Dose Escalation Cohort: Maximum tolerated dose (MTD) of ABBV-176 [ Time Frame: Minimum first cycle of dosing (up to 21 days) ]
    MTD will be defined as the highest dose level at which less than or equal to 33% of participants experience a dose limiting toxicity.
  • Dose Escalation Cohort: Recommended Phase 2 dose (RPTD) for ABBV-176 [ Time Frame: Minimum first cycle of dosing (up to 21 days) ]
    The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Cohort.
  • Expanded Recommended Phase Two Dose (RPTD) Cohort: Objective Response Rate (ORR) [ Time Frame: Up to approximately 2 years ]
    ORR is defined as the proportion of participants with a response of partial response (PR) or better per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • Dose Escalation Cohort: Cmax of ABBV-176 [ Time Frame: Up to approximately 57 days ]
    Maximum observed plasma concentration (Cmax) of ABBV-176.
  • Dose Escalation Cohort: Tmax of ABBV-176 [ Time Frame: Up to approximately 57 days ]
    Time to Cmax (Tmax) of ABBV-176
  • Dose Escalation Cohort: Terminal phase elimination rate constant (β) for ABBV-176 [ Time Frame: Up to approximately 57 days ]
    Terminal phase elimination rate constant (β)
  • Dose Escalation Cohort: t1/2 for ABBV-176 [ Time&nbs

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Expanded Recommended Phase Two Dose (RPTD) Cohort: Progression-Free Survival (PFS) [ Time Frame: Up to approximately 2 years ]
      PFS is defined as the time from the participant's first dose of study drug (Day 1) to the date of documented disease progression (per RECIST 1.1), or death due to any cause, whichever occurs first.
    • Expanded RPTD Cohort: Duration of Response (DOR) [ Time Frame: Up to approximately 2 years ]
      DOR is defined as the time from the date of the participant's documented first response of PR or better to the date of documented disease progression or death due to the disease, whichever occurs first.
    • Expanded RPTD Cohort: Overall Survival (OS) [ Time Frame: Up to 2 years after the last dose of study drug ]
      OS is defined as number of days from the date of the first dose to the date of death for all dosed subjects. For subjects who are not deceased, the data will be censored at the date of the last study visit, or the last know date to be alive, whichever is later.
    • Expanded RPTD Cohort: Change in ECOG Performance Status [ Time Frame: Up to approximately 2 years ]
      Change from baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
    • Expanded RPTD Cohort: Cmax of ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Maximum observed plasma concentration (Cmax) of ABBV-176.
    • Expanded RPTD Cohort: Tmax of ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Time to Cmax (Tmax) of ABBV-176
    • Expanded RPTD Cohort: Terminal phase elimination rate constant (β) for ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Terminal phase elimination rate constant (β) for ABBV-176
    • Expanded RPTD Cohort: t1/2 for ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Terminal elimination half-life (t1/2) for ABBV-176
    • Expanded RPTD Cohort: AUCt for ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt)
    • Expanded RPTD Cohort: AUC∞ for ABBV-176 [ Time Frame: Up to approximately 15 days ]
      Area Under the Plasma Concentration-time Curve from Time 0 to infinite time (AUC∞)
    • Dose Escalation Cohort: Change from Baseline in QTcF [ Time Frame: Up to approximately 47 days ]
      QT interval measurement corrected by Fridericia's formula (QTcF) mean change from baseline


    Original Secondary Outcome: Same as current

    Information By: AbbVie

    Dates:
    Date Received: May 5, 2017
    Date Started: June 9, 2017
    Date Completion: July 9, 2019
    Last Updated: May 5, 2017
    Last Verified: May 2017