Targeted Therapy RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with DNA Damage Repair Mutations (TRESR Study)

About the Study

This study is looking at how well a drug called called RP-3500 works either alone or when combined with other cancer treatments in people with different types of advanced cancers with a mutation in one of the following genes: BRCA1, BRCA2, ATM, RAD51B, RAD51C, RAD51D, ATRIP, CHTF8, FZR1, MRE11, NBN, RAD17, RAD50, REV3L, SETD2 or RNASEH2. RP-3500 is a type of oral, targeted therapy known as an ATR inhibitor. The combination prescribed will depend on cancer type and mutation and when people join the study.

What the Study Involves

• This is an open label study (no placebo). Everyone in the study will receive the study agent.
• Some people will receive RP-3500 alone and others will receive RP-3500 in combination with other drugs. The dosage, and whether you will receive RP-3500 alone or in combination will depend on:
  • your cancer type.
  • tumor mutations. 
  • availability of spots in the study at the time you join.
• In order to qualify participants will need to have lab tests, imaging studies, EKG’s and physical exams.
• Each group in the study will have slightly different visits. In general, most participants will be required to:
  • have weekly appointments for the first month.
  • have every-other-week appointments for the second month.
  • have monthly appointments thereafter. 
• Imaging scans to assess disease will be conducted approximately every two months
• Participants will receive a safety follow-up approximately 28 days after their last dose. 

Study Locations

Illinois

• Chicago
  Northwestern University

Massachusetts 

• Boston
  Dana Farber
  Lead Researcher: Geoffrey Shapiro
• Boston
  Massachusetts General Hospital
  Lead Researcher

New York

• New York City
  Memorial Sloane Kettering
  Lead Researcher: Allison Schram, MD

North Carolina

• Durham
  Duke Medical Center

Rhode Island

• Providence
  Rhode Island Hospital

Tennessee

• Nashville
  Sarah Cannon Research Institute
  Lead Researcher: David Spigel, MD

Texas

• Houston
  MD Anderson Cancer Center
  Lead Researcher: Timothy Yap, MD
  Study coordinator:
  Billy Hoadley: [email protected]

People with the following may be eligible to participate:

• advanced or metastatic cancer diagnosis
• at least 18 years old
• have an inherited or tumor mutation in one of the qualifying genes: BRCA1, BRCA2, ATM, ATRIP, CHTF8, FZR1, MRE11, NBN, RAD17, RAD50, RAD51B/C/D, REV3L, SETD2 or RNASEH2
• 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

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
• leptomeningeal metastases
• 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