Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Study Identifier
M24-311
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2023-505110-14
For general inquiries, please contact
Recruitment Complete
Sign up for trial alerts

Study Details

Medical Condition
  • Colorectal Cancer
  • Study Drug
  • ABBV-400
  • Bevacizumab
  • Folinic Acid
  • Fluorouracil
  • Irinotecan
  • Phase
    Phase 2
    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 adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer.

    ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab (FFB) is an approved drug for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with FFB in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own, ending with low or high doses of ABBV-400 in combination with FFB for continued dose optimization and expansion. Approximately 280 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide.

    In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with IV FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. During the dose optimization and expansion stage, participants will receive IV ABBV-400 in combination with IV FFB at low or high doses that have been determined from the previous stages. The study will run for a duration of approximately 3 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

    Study Locations

    Location
    Status
    Location
    Mayo Clinic Arizona /ID# 262610
    Phoenix, Arizona, United States, 85054
    Status
    Not applicable
    Location
    Highlands Oncology Group, PA /ID# 259424
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    City of Hope National Medical Center /ID# 257576
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365
    Irvine, California, United States, 92618
    Status
    Not applicable
    Location
    Yale School of Medicine /ID# 257494
    New Haven, Connecticut, United States, 06519
    Status
    Not applicable
    Location
    Mayo Clinic Hospital Jacksonville /ID# 262609
    Jacksonville, Florida, United States, 32224
    Status
    Not applicable
    Showing {first} - {last} of {total} Results