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

NCT05021900 | Completed Phase 2 Results

• 1 other identifier: RP6530-2101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

Locally Advanced Breast Cancer; Metastatic Breast Cancer

Keywords

RP6530; Tenalisib

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Without Disease Progression

  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.

  Approximately 6 months

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Approximately 18 months

• Clinical Benefit Rate (CBR)

  Approximately 18 months

• Progression Free Survival (PFS).

  Approximately 18 months

• Treatment Emergent Adverse Events (TEAEs)

  Approximately 18 months

Study Arms (2)

Tenalisib 800 mg BID

EXPERIMENTAL

Single agent at a dose of 800 mg BID

Drug: Tenalisib 800mg

Tenalisib 1200 mg BID

EXPERIMENTAL

Single agent at a dose of 1200 mg BID

Drug: Tenalisib 1200mg

Interventions

Tenalisib 800mg DRUG

Tenalisib will be administered 800mg BID, orally

Also known as: RP6530

Tenalisib 800 mg BID

Tenalisib 1200mg DRUG

Tenalisib will be administered 1200mg BID, orally

Also known as: RP6530

Tenalisib 1200 mg BID

Eligibility Criteria

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

You may qualify if:

• Patients must be ≥18 years of age, at the time of signing informed consent.
• 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.
• 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.
• Life expectancy of at least 3 months.
• Adequate bone marrow, liver, and renal functions
• Female patients of childbearing potential should be willing to use a medically acceptable method of contraception

You may not qualify if:

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

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (3)

High Technology Hospital Medcenter

Batumi, Georgia

Location

LLC Caucasus Medical Center

Tbilisi, 0186, Georgia

Location

Simon Khechinashvili University Hospital

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

This is an open label study in a limited number of subjects.

Results Point of Contact

• Title: Dr. Prajak Barde
• Organization: Rhizen Pharmaceuticals AG

pjb@rhizen.com

+919820503970

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: October 13, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-08

Locations

GE (3)