Targeted Therapy RP-3500 Alone or in Combination with Talazoparib or Gemcitabine in Advanced Solid Tumors with DNA Damage Repair Mutations (TRESR Study)
Advanced solid tumors
Study Contact Information:
Billy Hoadley [email protected]
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.
Lead Researcher: Geoffrey Shapiro
Massachusetts General Hospital
- New York City
Memorial Sloane Kettering
Lead Researcher: Allison Schram, MD
Duke Medical Center
Rhode Island Hospital
Sarah Cannon Research Institute
Lead Researcher: David Spigel, MD
MD Anderson Cancer Center
Lead Researcher: Timothy Yap, MD
Billy Hoadley: [email protected]
This Study is Open To:
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.
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 systemic therapy including Hepatitis B, Hepatitis C, HIV+
- pregnant or breast-feeding
- other known active cancer(s)
- history of clinically significant heart disease
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.