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AbbVie M16-438 for Colorectal Cancer or Glioblastoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety of a new drug, ABBV-321 when given to patients with colorectal cancer or glioblastoma.

We start with a Dose Escalation phase is to find the highest dose that can be safely tolerated by patients, which is called the Maximum Tolerated Dose (MTD).

We then do an Expanded Safety phase to get a better understanding of the safety of the drug at the MTD in a larger number of people.

What is the Condition Being Studied?

Advanced or metastatic colorectal cancer or glioblastoma (brain tumor)

Who Can Participate in the Study?

Adults men and women who:
- Are diagnosed with colorectal cancer or glioblastoma.

Age Group
Adults

What is Involved?

There are two phases to this study:
Phase 1 is a Dose Escalation phase where the study drug will be given in higher doses until the highest safe dose is found
Phase 2 is an Expanded Safety phase where patients will be monitored for side effects of the drug at the dose found in Phase 1.

If you choose to join the Dose Escalation phase, you will get the study drug (ABBV-321) through a vein once every 28 days.
If you join the study during the Expanded Safety phase, you will receive ABBV-321 at the dose found to be the safest in Phase 1 once every 28 days.

Study Details

Full Title
Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-Tumor Activity of ABBV-321 in Subjects with Advanced Solid Tumors Associated with Overexpression of the Epidermal Growth Factor Receptor (EGFR) or its Ligands
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00086471
NCT:NCT03234712
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698