General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT06107413

Background Information

The purpose of this research study is to see if ABBV-400 has any benefits at dose levels thought to be acceptable in earlier studies. The researchers want to find out what effects (good and bad) ABBV-400 has on metastatic colorectal cancer.

The goal of this study is to determine the optimal dose level for the study drug ABBV-400 in combination with 5-FU, folinic acid, and bevacizumab to define the recommended Phase 3 dosage regimen for the combination and to evaluate the efficacy (how well the study drug works), safety and tolerability of the study drug in patients with unresectable metastatic colorectal cancer who have received prior therapy for this colorectal cancer and have progressed during or after the prior treatment.

For more information, please visit: https://clinicaltrials.gov/study/NCT06107413

Offered At

Inova Schar Cancer
A Division of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031
Principal Investigator

Arthur Winer, MD

Eligibility Information

  • Adult individuals, at least 18 years old
  • ECOG performance status of 0 or 1
  • Histologically or cytologically confirmed unresectable metastatic colorectal cancer
  • Progression on/after only one 1L systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy, defined as:
    • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine) plus oxaliplatin, for example FOLFOX or CAPOX, with or without: an anti-EGFR antibody (including, but not limited to cetuximab or panitumumab) or an anti-VEGF monoclonal antibody (including, but not limited to bevacizumab or ramucirumab)
    • Subjects may have received prior (neo)adjuvant therapy (e.g., FOLFOX, CAPOX); if progression has occurred within 12 months from the last dose of (neo)adjuvant treatment, this regimen will be considered as the one line of systemic therapy for advanced disease
      Note: Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period.
  • Females who are not pregnant or breastfeeding, and is not considering becoming pregnant or donating eggs during the study or for approximately 280 days after the last dose of study drug
  • Additional inclusion criteria in protocol

Ineligibility Information

  • Pregnancy/breastfeeding
  • BRAF V600E mutation and are not dMMR+/MSI-H
  • Prior systemic regimen containing Irinotecan or c-Met targeting antibody or ADC
  • History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate >90%)
  • Subjects infected with HIV may be enrolled if the following criteria are met:
    • CD4 count is ≥ 100 cells/μL. (If CD4 count is < 200 cells/μL, a CD4 to CD8 ratio > 0.4 is required.) Subject has been receiving effective ART for at least 4 weeks with an HIV viral load of less than 200 copies/mL, and subject has no symptomatic AEs higher than Grade 1 attributed to ART
  • Additional ineligibility in protocol