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

Recruiting now · Phase 2

Conditions studied: Triple Negative Breast Cancer (TNBC)

In brief

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.

Key facts

Study ID

NCT06189209

Run by

Rhizen Pharmaceuticals SA

People needed

40

Starts

2024-03-04

Expected to finish

2027-03-31

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Health Point Hospital — Kolkata, West Bengal, India (enrolling)
• Narayana Hrudayala Majumdar Shaw Hospital — Bangalore, Karnataka, India (enrolling)
• Tata Memorial Centre — Mumbai, Maharashtra, India (enrolling)
• Mumbai Oncocare Centre — Mumbai, Maharashtra, India (enrolling)
• Sahyadri Super Speciality Hospital — Pune, Maharashtra, India (enrolling)
• Nobel Hospital — Pune, Maharashtra, India (enrolling)
• HCG City Cancer Center — Vijayawada, Andhra Pradesh, India (enrolling)
• Nizams Institute of Medical Science — Hyderabad, Telangana, India
• Meenakshi Mission Hospital & Research Center — Madurai, Tamil Nadu, India

Full record on ClinicalTrials.gov

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