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

NCT05002868 | Completed Phase 1

• 1 other identifier: RP12146-2101
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 6

Brief 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

Keywords

PARP

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  2 years

Secondary Outcomes (6)

• Tmax

  Day 1 to Day 28

• Cmax

  Day 1 to Day 28

• AUC

  Day 1 to Day 28

• Overall response rate (ORR)

  2 years

• Clinical benefit rate (CBR)

  2 years

Study Arms (1)

RP12146

EXPERIMENTAL

RP12146 will be administered orally daily (QD or BID)

Drug: RP12146

Interventions

RP12146 DRUG

starting dose of 100 mg QD

RP12146

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of full informed consent prior to any study-specific procedures.
• Patients must be ≥18 years of age, at the time of signing informed consent.
• 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.
• 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.
• 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.
• ECOG performance status 0 to 2.
• Use of contraception measures

You may not qualify if:

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

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (6)

Multiscan s.r.o.

Hořovice, 268 31, Czechia

Location

SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street

Krakow, 50 Kopernika Street, Poland

Location

Klinika Onkologii ICZMP

Lodz, 93-338, Poland

Location

Pratia Poznań Medical Center

Poznan, Poland

Location

Clinical Trials Site Nasz Lekarz

Torun, Poland

Location

Maria Skłodowska-Curie Memorial National Oncology Institute

Warsaw, Poland

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 12, 2021
• Study Start: October 5, 2021
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5); CZ (1)