STUDY TITLE: A Phase 2, Randomized, Open-Label Study Comparing Telisotuzumab Adizutecan (ABBV-400) Monotherapy to the Current Standard of Care in Subjects With Post Adjuvant ctDNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (NED) Adenocarcinomas

NCT07023289

This is a Phase 2 study to assess adverse events and change in disease activity in adult participants receiving intravenously infused Telisotuzumab Adizutecan alone or with standard of care in participants with post adjuvant circulating tumor DNA positive colorectal cancer and no radiographic evidence of disease.

Status: Active, Recruiting

Key Eligibility Criteria

  • Patients with confirmed colon or rectal adenocarcinoma
  • Patients must:
    • have received at least 3 months of platinum-based doublet adjuvant chemotherapy, excluding topoisomerase inhibitors
    • have no radiographic evidence of disease within 6 weeks prior to first study dose
    • have ctDNA positive assay after the end of adjuvant therapy

Treatment

Drug: Telisotuzumab Adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1

Study Plan