NCT05002868

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Extensive-stage Small-cell Lung Cancer
• Locally Advanced Breast Cancer
• Metastatic Breast Cancer
• Platinum-sensitive Ovarian Cancer
• Platinum-Sensitive Fallopian Tube Carcinoma
• Platinum-Sensitive Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	RP12146	starting dose of 100 mg QD

Timeline

• Start date: 2021-10-05
• Primary completion: 2024-04-25
• Completion: 2024-04-25
• First posted: 2021-08-12
• Last updated: 2024-09-19

Locations

6 sites across 2 countries: Czechia, Poland