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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05002868
Other study ID # RP12146-2101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 5, 2021
Est. completion date April 25, 2024

Study information

Verified date May 2024
Source Rhizen Pharmaceuticals SA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 25, 2024
Est. primary completion date April 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RP12146
starting dose of 100 mg QD

Locations

Country Name City State
Czechia Multiscan s.r.o. Horovice
Czechia FN Olomouc, Oncology clinic, Olomouc
Poland Klinika Onkologii ICZMP Lódz
Poland Pratia Poznan Medical Center Poznan
Poland Clinical Trials Site Nasz Lekarz Torun
Poland Maria Sklodowska-Curie Memorial National Oncology Institute Warszawa

Sponsors (1)

Lead Sponsor Collaborator
Rhizen Pharmaceuticals SA

Countries where clinical trial is conducted

Czechia,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Tmax Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146 Day 1 to Day 28
Secondary Cmax Pharmacokinetics: Maximum Concentration (Cmax) of RP12146 Day 1 to Day 28
Secondary AUC Pharmacokinetics: Area Under the Concentration Curve (AUC) of RP12146 Day 1 to Day 28
Secondary Overall response rate (ORR) Sum of the percentages of Complete Response and Partial Response 2 years
Secondary Clinical benefit rate (CBR) Sum of the percentages of Complete response, partial response and stable disease 2 years
Secondary Progression free survival (PFS) It is defined as time from the first dose of study treatment to documented disease progression 2 years
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