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Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05002868•Rhizen Pharmaceuticals SA

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Provision of full informed consent prior to any study-specific procedures.
•2. Patients must be ≥18 years of age, at the time of signing informed consent.
•3. Dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. Tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer.
•4. Dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), with one of the documented deleterious mutations of specified HRR genes and whose disease has progressed following at least one standard therapy.
•5. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment at follow up-visits.
•6. ECOG performance status 0 to 2.
•7. Use of contraception measures

Exclusion Criteria

•1. Patients with HER2 positive breast cancer
•2. Patients receiving anticancer therapy
•3. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
•4. Prior treatment with a PARP inhibitor
•5. Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
•6. Patient with symptomatic uncontrolled brain metastasis.
•7. Pregnancy and lactation
•8. Patients with uncontrolled disease

Locations (6)

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

Key Dates

Start Date

October 5, 2021

Primary Completion Date

April 25, 2024

Completion Date

April 25, 2024

Last Updated

September 19, 2024

Enrollment

ACTUAL participants

Conditions

Solid TumorExtensive-stage Small-cell Lung CancerLocally Advanced Breast CancerMetastatic Breast CancerPlatinum-sensitive Ovarian CancerPlatinum-Sensitive Fallopian Tube CarcinomaPlatinum-Sensitive Peritoneal Cancer

Interventions

RP12146

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE1

A Study of PYX-201 in Advanced Solid Tumors

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Solid TumorAdvanced Solid Tumor

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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