A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors

Study Identifier
M16-573
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • ABBV-155
  • Paclitaxel
  • Docetaxel
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    An open-label, dose-escalation (Part 1), dose-expansion (Part 2) study to assess the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-155 alone and in combination with paclitaxel or docetaxel.

    In Part 1 (dose escalation), participants will receive escalating doses of ABBV-155 monotherapy (Part 1a) or ABBV-155 in combination with paclitaxel or docetaxel (Part 1b).

    In Part 2 (dose expansion), participants will receive ABBV-155 monotherapy or in combination therapy. The ABBV-155 monotherapy cohort will enroll participants with relapsed or refractory (R/R) small cell lung cancer (SCLC) (Part 2a); the ABBV-155 plus a taxane (paclitaxel or docetaxel) combination cohort will enroll participants with R/R non-small cell lung cancer (NSCLC) and breast cancer (Part 2b).

    Study Locations

    Location
    Status
    Location
    University of Alabama at Birmingham - Main /ID# 214024
    Birmingham, Alabama, United States, 35233
    Status
    Not applicable
    Location
    Highlands Oncology Group, PA /ID# 201568
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 206105
    Orange, California, United States, 92868-3201
    Status
    Not applicable
    Location
    Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 204267
    West Hollywood, California, United States, 90048
    Status
    Not applicable
    Location
    Univ of Colorado Cancer Center /ID# 208365
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Yale University, Yale Cancer Center /ID# 201542
    New Haven, Connecticut, United States, 06510-3206
    Status
    Not applicable
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