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Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06189209•Rhizen Pharmaceuticals SA

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients who have histologically confirmed TNBC.
•2. Patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting.
•3. Patients with at least one measurable lesion, per RECIST version 1.1 at baseline . Bone-only disease is not permitted.
•4. ECOG performance status 0 to 2.
•5. Adequate bone marrow, liver, and renal function

Exclusion Criteria

•1. Cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter).
•2. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
•3. Prior exposure to PI3K inhibitors (e.g., alpelisib, buparlisib) for breast cancer.
•4. Major surgery within 4 weeks of starting study treatment.
•5. Patient with symptomatic uncontrolled brain metastasis.
•6. Ongoing immunosuppressive therapy including systemic corticosteroids.
•7. History of severe cutaneous reactions.
•8. Concurrent disease or condition that would interfere with study participation
•9. Pregnancy or lactation.
•10. Any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation

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

Key Dates

Start Date

March 4, 2024

Primary Completion Date

December 31, 2026

Completion Date

March 31, 2027

Last Updated

December 2, 2025

Enrollment

ESTIMATED participants

Conditions

Triple Negative Breast Cancer (TNBC)

Interventions

Tenalisib

DRUG

Contacts

Prajak Barde, MD

CONTACT

+41325800175 pjb@rhizen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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