drugset / Trial / NCT05002868

Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors

NCT05002868 ↗

Phase 1 Completed 23 enrolled Rhizen Pharmaceuticals SA
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-10-05
Primary completion
2024-04-25
Completion
2024-04-25

Drugs

EvaluationDrugModalityDoseRoute
Subject RP12146 Unknown 100 mg Oral