A Study of the Investigational Targeted Therapy ART4215 to Treat Advanced or Metastatic Solid Tumors

About the Study

This study is looking at how well a drug called ART4215 works either alone or when combined with the PARP inhibitor talazoparib in people with different types of advanced cancers. ART4215 is an oral, targeted therapy that is designed to keep cancer cells from repairing DNA damage. 

What the Study Involves

• This is an open label study - everyone in the study will receive ART4215. 
• Some people will receive ART4215 alone and others will receive ART4215 in combination with talazoparib. The dosage, and whether you will receive ART4215 alone or in combination will depend on:
  • your cancer type.
  • tumor mutations. 
  • availability of spots in the study at the time you join.
• Each group in the study will have slightly different visits. In general, most participants will be required to:
  • have weekly appointments for the first six weeks.
  • have appointments every three weeks thereafter. 
• In order to qualify, participants will need to have lab tests, imaging studies, EKG’s, echocardiogram, biopsy, physical exam, and an eye exam.
• ART4215 and talazoparib are both taken orally. The number of pills and the days you take them is dependent on which arm you are enrolled in.
• Participants will receive a safety follow-up approximately 28 days after their last dose.

Study Locations

Florida

• Olando
  Florida Cancer Specialist
  PI: Dr. Cesar Perez

Oklahoma

• Oklahoma City
  Oklahoma University
  PI: Dr. Kathleen Moore
  Contact: [email protected] 

Tennessee

• Nashville
  Tennessee Oncology
  PI Dr. Erika Hamilton

Texas 

• Houston
  MD Anderson Cancer Center
  PI: Dr Timothy Yap
  Contact: [email protected]

People with the following may be eligible to participate:

• advanced or metastatic cancer diagnosis
• at least 18 years old;
• willing to provide blood and tumor tissue samples for testing if required
• any treatment-related toxicity has been resolved
• adequate immune, blood count, liver, kidney function
• otherwise in reasonably good health

Additionally:

• some participants will require a biopsy as part of the study
• prior treatment with PARP inhibitors allowed for some participant groups

Check study listing on clinicaltrials.gov or contact study coordinator for additional eligibility. 

People with the following are not eligible:

• less than 21 days from last treatment
• history of prolonged low blood cell counts
• brain metastases, unless treated and stable
• active infection(s) requiring systemic therapy including Hepatitis B, Hepatitis C, HIV+
• pregnant or breast-feeding
• other known active cancer(s)
• history of clinically significant heart disease