Duke logo

AbbVie M16-438 (Colorectal cancer or Glioblastoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the new drug, ABBV-321 is safe 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?

Colorectal cancer or Glioblastoma (brain tumor)

Who Can Participate in the Study?

Adults who are diagnosed with colorectal cancer or glioblastoma.

Age Group
Adults

What is Involved?

There are two phases to this study:

Phase 1 is where the study drug ABBV-321 will be given through a vein once every 28 days and will be given in higher doses until we can get the highest and safest dose.

Phase 2 is where patients will be watched for side effects (good or bad) of the study drug ABBV-321 (given through a vein) at the dose found in Phase 1.

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)
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00086471
NCT:NCT03234712
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698