Vaccination with ATP128 +/- an immune checkpoint inhibitor for stage IV colorectal cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to see if the study drugs, ATP128 and BI 754091, are safe and effective for fighting your cancer.

What is the Condition Being Studied?

Colorectal Cancer

Who Can Participate in the Study?

Adults with stage 4 colorectal cancer who:
- Completed at least 6 months of chemotherapy, during which time their tumors shrank or stayed the same size; OR
- Received up to 12 weeks of chemotherapy and have a liver metastasis that is eligible to be removed by surgery

Age Group

What is Involved?

If you choose to join this study, you will:
- Get the study drug ATP128 by injection once every 2-to-4 weeks for 4 months
- Get the study drug BI 754091 by I.V. once every 3 weeks for 4.5-to-12 months
- Have surgery to remove your liver metastasis (if applicable)
- Give blood and urine samples
- Have regular CT or MRI scans

Study Details

Full Title
[KISIMA-01] 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
Principal Investigator
Protocol Number
IRB: PRO00107595
NCT: NCT04046445
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center