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

Phase 1

Completed

• Conditions: Locally Advanced Breast Cancer; Platinum-Sensitive Fallopian Tube Carcinoma; Platinum-Sensitive Peritoneal Cancer; Solid Tumor; Metastatic Breast Cancer; Extensive-stage Small-cell Lung Cancer; Platinum-sensitive Ovarian Cancer
• Interventions: Drug: RP12146

• Registration Number: NCT05002868
• Lead Sponsor: Rhizen Pharmaceuticals SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-05
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Study Start: 2021-10-05
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RP12146	RP12146	RP12146 will be administered orally daily (QD or BID)

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors	28 days	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
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0	2 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street; 🇵🇱 Kraków, Poland

Multiscan s.r.o.; 🇨🇿 Hořovice, Czechia

Pratia Poznań Medical Center; 🇵🇱 Poznań, Poland

Clinical Trials Site Nasz Lekarz; 🇵🇱 Toruń, Poland

Maria Skłodowska-Curie Memorial National Oncology Institute; 🇵🇱 Warszawa, Poland

Klinika Onkologii ICZMP; 🇵🇱 Łódź, Poland