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

NCT ID: NCT05002868

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2024-04-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RP12146

RP12146 will be administered orally daily (QD or BID)

Group Type: EXPERIMENTAL

RP12146

Intervention Type: DRUG

starting dose of 100 mg QD

Interventions

RP12146

starting dose of 100 mg QD

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhizen Pharmaceuticals SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Czechia; Poland

Other Identifiers

RP12146-2101

Identifier Type: -

Identifier Source: org_study_id