An Open-Label Multicenter Non-Randomized Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety Tolerability and Anti-Tumor Activity of ATP128 With or Without BI 754091 in Patients With Stage IV Colorectal Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Colorectal Cancer
  • Age: Between 18 years - 100 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Patient with histologically or cytologically confirmed stage IV colorectal cancer who has failed standard therapies. 2) Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 as determined by the local site investigator/radiologist assessment. 3) Presence of at least one liver lesion amenable to repeated biopsy, ideally not the one being used for measuring. 4) Willingness to undergo two fresh liver biopsies (pre-treatment and on-treatment).

You may not be eligible for this study if the following are true:

  • 1) Gastro-intestinal bowel obstruction (partial or complete). 2) Participation in any other study with an investigational study drug or device requires Medical Monitor approval. 3) Prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study treatment with the exception of bevacizumab (Avastin┬«) which may have been received within 15 days from initiation of study treatment. 4) Prior therapy with checkpoint inhibitors (anti-programmed death 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4).

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