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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
starting dose of 100 mg QD
Multiscan s.r.o.
Hořovice, Czechia
SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street
Krakow, Poland
Klinika Onkologii ICZMP
Lodz, Poland
Pratia Poznań Medical Center
Poznan, Poland
Clinical Trials Site Nasz Lekarz
Torun, Poland
Maria Skłodowska-Curie Memorial National Oncology Institute
Warsaw, Poland
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
Time frame: 28 days
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0
Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.
Time frame: 2 years
Tmax
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146
Time frame: Day 1 to Day 28
Cmax
Pharmacokinetics: Maximum Concentration (Cmax) of RP12146
Time frame: Day 1 to Day 28
AUC
Pharmacokinetics: Area Under the Concentration Curve (AUC) of RP12146
Time frame: Day 1 to Day 28
Overall response rate (ORR)
Sum of the percentages of Complete Response and Partial Response
Time frame: 2 years
Clinical benefit rate (CBR)
Sum of the percentages of Complete response, partial response and stable disease
Time frame: 2 years
Progression free survival (PFS)
It is defined as time from the first dose of study treatment to documented disease progression
Time frame: 2 years
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