SAR39459 alone or in combination with cemiplimab in adults with advanced solid tumors - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the possible risks of the study drug (SAR439459) given alone or in combination with cemiplimab. We are also want to see how well the study drug works.

What is the Condition Being Studied?

Colorectal Cancer, Hepatocellular Carcinoma (HCC), Urothelial Cancer, and Melanoma

Who Can Participate in the Study?

Adults, 18+ who:
- Have been diagnosed with advanced unresectable or metastatic melanoma (excluding uveal melanoma), colorectal cancer, urothelial cancer, or hepatocellular carcinoma
- Are willing to have a fresh biopsy of their tumor
- Do not have HIV, uncontrolled Hepatitis B, or untreated current Hepatitis C

Age Group

What is Involved?

If you choose to join this study you will:
-Go through a screening period which will last about 4 weeks
-Have physical exams
-Have lab tests and other screening tests to see if you qualify for the study

If you’re able to join, you will:
-Get the study drug (SAR439459) by itself or in combination with cemiplimab once every 3 weeks via an intravenous (into the vein) infusion
-Have physical exams, lab tests, and other tests done throughout the study

Study Details

Full Title
A Phase 1/1b first-in-human dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR439459 administered intravenously as monotherapy and in combination with Cemiplimab in adult patients with advanced solid tumors
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00100491
NCT: NCT03192345
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center