Spots Global Cancer Trial Database for Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors
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Trial Identification
Brief Title: Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors
Official Title: A Multi-center, Open-label, Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT05002868
Interventions
Study Description
Brief Summary: An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Multiscan s.r.o., Hořovice, , Czechia
FN Olomouc, Oncology clinic,, Olomouc, , Czechia
Pratia Poznań Medical Center, Poznań, , Poland
Clinical Trials Site Nasz Lekarz, Toruń, , Poland
Maria Skłodowska-Curie Memorial National Oncology Institute, Warszawa, , Poland
Klinika Onkologii ICZMP, Łódź, , Poland
Contact Details
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