RecruitingPhase 2NCT06189209

Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)


Sponsor

Rhizen Pharmaceuticals SA

Enrollment

40 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase II, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic TNBC, who have received at least one but not more than 3 prior therapies in a metastatic setting.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of tenalisib — a targeted oral drug — in people with metastatic triple-negative breast cancer (TNBC), an aggressive form of breast cancer that does not respond to hormone therapies or HER2-targeted drugs and has limited treatment options. **You may be eligible if...** - You have triple-negative breast cancer confirmed by biopsy - Your cancer has spread to other parts of the body (metastatic) - You have received between 1 and 3 prior chemotherapy regimens for metastatic disease - You have at least one measurable tumor (not bone-only disease) - You are in reasonably good health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have active brain metastases - You have received more than 3 prior chemotherapy regimens in the metastatic setting - You have only bone metastases with no other measurable disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTenalisib

Tenalisib will be administered 800mg/ 400mg BID, orally


Locations(9)

HCG City Cancer Center

Vijayawada, Andhra Pradesh, India

Narayana Hrudayala Majumdar Shaw Hospital

Bangalore, Karnataka, India

Tata Memorial Centre

Mumbai, Maharashtra, India

Mumbai Oncocare Centre

Mumbai, Maharashtra, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Nobel Hospital

Pune, Maharashtra, India

Meenakshi Mission Hospital & Research Center

Madurai, Tamil Nadu, India

Nizams Institute of Medical Science

Hyderabad, Telangana, India

Health Point Hospital

Kolkata, West Bengal, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06189209


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