Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: Tenalisib 1200mg; Drug: Tenalisib 800mg

• Registration Number: NCT05021900
• Lead Sponsor: Rhizen Pharmaceuticals SA

Brief Summary

Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.

Detailed Description

The study will have two groups, Group 1 with a treatment option of 800mg RP6530 BID and Group 2 with a treatment option of 1200mg RP6530 BID, where the subjects will be randomly assigned to each group in 1:1 and continued on each group of treatment till disease progressed.

Study Timeline

• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-08-19
• Study First Posted: 2021-08-26
• Study Start: 2021-10-13
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Results First Submitted: 2023-07-25
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

1. Patients must be ≥18 years of age, at the time of signing informed consent.
2. Female patients who have histologically and/or cytologically confirmed locally advanced or metastatic breast cancer that has progressed following at least one line of therapy.
3. 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.
4. ECOG performance status 0 to 2.
5. Life expectancy of at least 3 months.
6. Adequate bone marrow, liver, and renal functions
7. Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

Exclusion Criteria

1. Patients with HER-2 positive breast cancer.
2. Patients receiving anticancer therapy within 4 weeks or 5 half-lives of the drug prior to C1D1, whichever is shorter.
3. Patient who has not recovered from acute toxicities (defined as NCI-CTCAE grade > 1) of previous therapy except treatment-related alopecia.
4. Patients who have had disease progression within 8 weeks of platinum chemotherapy.
5. Prior exposure to investigational or marketed PI3K inhibitors given for the treatment of breast cancer.
6. Major surgery within 4 weeks of starting study treatment OR any patient who has not recovered from the effects of major surgery.
7. Patient with symptomatic uncontrolled brain metastasis.
8. HIV-positive patients who are on antiretroviral therapy OR active hepatitis C OR active hepatitis B virus infections.
9. Ongoing immunosuppressive therapy including systemic corticosteroids except as allowed per concomitant medication.
10. Known history of severe liver injury as judged by the investigator.
11. History of severe cutaneous reactions in the past.
12. Active gastrointestinal tract disease with malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease such as Crohn's disease or ulcerative colitis.
13. Pregnancy or lactation.
14. Patient with other active malignancies at the time of screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenalisib 1200 mg BID	Tenalisib 1200mg	Single agent at a dose of 1200 mg BID
Tenalisib 800 mg BID	Tenalisib 800mg	Single agent at a dose of 800 mg BID

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Without Disease Progression	Approximately 6 months	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures

Name	Time	Method
Clinical Benefit Rate (CBR)	Approximately 18 months	It is defined as sum of CR, PR and SD rates
Overall Response Rate (ORR)	Approximately 18 months	Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Progression Free Survival (PFS).	Approximately 18 months	PFS is measured from the time of first dose of study drug to radiographic documentation of disease progression or death due to any cause.
Treatment Emergent Adverse Events (TEAEs)	Approximately 18 months	Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product.

Trial Locations

Locations (3)

High Technology Hospital Medcenter; 🇬🇪 Batumi, Georgia

LLC Caucasus Medical Center; 🇬🇪 Tbilisi, Georgia

Simon Khechinashvili University Hospital; 🇬🇪 Tbilisi, Georgia