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

NCT05002868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-09-19

No results posted yet for this study

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

DRUG

RP12146

starting dose of 100 mg QD

Sponsors & Collaborators

  • Rhizen Pharmaceuticals SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Czechia
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002868 on ClinicalTrials.gov