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

Clinicaltrials.gov identifier:
NCT04497116

Treatment
Advanced solid tumors

Study Contact Information:

Study coordinator:
Billy Hoadley [email protected]

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: , , , RAD51B, , , ATRIP, CHTF8, FZR1, MRE11, , RAD17, , REV3L, SETD2 or RNASEH2. RP-3500 is a type of oral,  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 ). 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]
This Study is Open To:

People with the following may be eligible to participate:

  • advanced or  cancer diagnosis
  • at least 18 years old
  • have an inherited or tumor mutation in one of the qualifying genes: , , , ATRIP, CHTF8, FZR1, MRE11, , RAD17, , RAD51B/C/D, REV3L, SETD2 or RNASEH2
  • willing to provide blood and tumor tissue samples for testing if required
  • any treatment-related  has been resolved
  • adequate immune, blood count, liver, kidney function

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

This Study is Not Open To:

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  including Hepatitis B, Hepatitis C, HIV+
  • pregnant or breast-feeding
  • other known active cancer(s)
  • history of clinically significant heart disease