Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors

Study Identifier
M23-385
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-504598-18-00
For general inquiries, please contact
Recruitment Complete
Sign up for trial alerts

Study Details

Medical Condition
  • Solid Tumors (General)
  • Study Drug
  • ABBV-706
  • Cisplatin
  • Budigalimab
  • Carboplatin
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy and in combination with budigalimab, carboplatin, or cisplatin.

    ABBV-706 is an investigational drug being developed for the treatment of small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine carcinomas (NECs). There are multiple treatment arms in this study. Participants will either receive ABBV-706 as a single agent or in combination with budigalimab (another investigational drug), carboplatin or cisplatin at different doses. Approximately 319 adult participants will be enrolled in the study across sites worldwide.

    In part 1 (dose escalation), ABBV-706 will be intravenously infused in escalating doses as a monotherapy until the maximum tolerated dose (MTD) is determined in participants with SCLC, high-grade CNS tumors, and high-grade NECs. In part 2, multiple doses will be selected from Part 1 and SCLC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. In Part 3a, participants with SCLC or NECs will receive ABBV-706 in combination with budigalimab intravenously every 3 weeks. In Part 3b participants with SCLC or NECs will receive ABBV-706 in combination with either carboplatin or cisplatin intravenously. In Part 4a, participants with CNS tumors will receive ABBV-706 intravenously at a dose determined from Part 1. In Part 4b, participants with NECs will receive ABBV-706 intravenously at a dose selected from Part 1. The estimated duration of the study is up to 4 years.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

    Study Locations

    Location
    Status
    Location
    Banner MD Anderson Cancer Ctr /ID# 260129
    Gilbert, Arizona, United States, 85234
    Status
    Not applicable
    Location
    City Of Hope Comprehensive Cancer Center /ID# 271295
    Duarte, California, United States, 91030
    Status
    Not applicable
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 259884
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    Yale New Haven Hospital /ID# 246647
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    Georgetown University Hospital /ID# 255352
    Washington D.C., District of Columbia, United States, 20007
    Status
    Not applicable
    Location
    University of Chicago Medical Center /ID# 256334
    Chicago, Illinois, United States, 60637
    Status
    Not applicable
    Showing {first} - {last} of {total} Results