Colorectal Cancer: 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 (N

The purpose of this study is to determine if ABBV-400 given alone (monotherapy) will delay relapse in and potentially cure subjects with colorectal cancer who have positive ctDNA test after surgical removal of tumor and chemotherapy (adjuvant therapy).  

ctDNA stands for "circulating tumor" DNA, which means that cancer cells can be detected in your body before, during or after therapy. Patients with detectable ctDNA after surgery and chemotherapy have a higher risk of recurrence compared with ctDNA negative patients.  

Currently after adjuvant therapy, patients do not receive further treatment but instead undergo tumor imaging scans such as CT/MRI to assess for tumor recurrence. 

8081 Innovation Park Drive
Fairfax, VA 22031

• Surgical tumor material should be available and must be submitted for Signatera™ personalized
  panel and assessment of c-Met protein levels.
• ECOG PS of 0 or 1 within the screening period prior to the first dose of study treatment.
• Resolution of any acute clinically significant treatment-related toxicity from prior therapy to 
  Grade ≤ 1 or baseline prior to study entry, except for anemia (Grade ≤ 2), neutropenia 
  (Grade ≤ 2), peripheral neuropathy (Grade ≤ 2), and alopecia (any grade).
• Subject has histologically or cytologically confirmed adenocarcinoma of the colon or rectum (all 
  other histological types are excluded).
• No live vaccine within 7 days prior to study C1D1 and during the study. When possible, there 
  should be at least 3 days between administration of inactivated, live attenuated vaccines, or the 
  SARS-CoV-2 vaccine and study treatment administration. The first dose of telisotuzumab 
  adizutecan, when possible, is preferred to be given at least 7 days after the SARS-CoV-2 vaccine 
  administration.
• Individuals of childbearing potential must practice at least 1 protocol-specified method of birth 
  control, that is effective from Study Day 1 through at least 250 days after the last dose of study 
  treatment.
• No pregnancy or breastfeeding, or intention of becoming pregnant or donating eggs during 
  study treatment or within at least 250 days after the last dose of telisotuzumab adizutecan.
  • Individuals of childbearing potential must have a negative serum pregnancy test result within 
    14 days prior to initiation of study treatment and a negative urine or serum (per local guidelines) 
    pregnancy test at baseline prior to initiation of study drug.

• No availability of surgical tissue sample.
• History of ILD or pneumonitis that required treatment with systemic steroids, or any evidence of 
  active ILD or pneumonitis on screening chest CT scan.
• Treated or untreated brain or meningeal metastases.
• History of other malignancies within 3 years prior to screening, except for malignancies with a 
  negligible risk of metastasis or death (e.g., 5-year OS rate > 90%).
• QTc ≥ 470 msec (using Fridericia's correction), any Grade 3 arrythmia, and any other clinically 
  significant cardiac abnormalities.
• Active systemic or uncontrolled local bacterial, fungal, or viral infection requiring anti-microbial 
  therapy.
• History of an allergic reaction or significant sensitivity to constituents of the study treatment 
  and/or other products in the same class.
• History of clinically significant medical conditions or any other reason that the investigator 
  determines would interfere with the subject's participation in this study or would make the 
  subject an unsuitable candidate to receive study treatment.
• History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 
  6 months.