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Recruiting Phase 2

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

NCT06189209 · tracked via the Priya Life Science India tracker
Sponsor
Rhizen Pharmaceuticals SA
Phase
Phase 2
Started
2024-03-04
Last updated
2025-12-02

Condition(s) studied

Triple Negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

Tenalisib

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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical Benefit Rate (CBR) — 1 year
    It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.
  • Duration of Clinical Benefit (DoCB) — 1 year
    It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first in patients who achieve CR, PR or SD for 16 weeks or longer.
  • Overall Response Rate (ORR) — 1 year
    Overall Response is defined as sum of CR and PR.
  • Progression Free Survival (PFS) — 1 year
    It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.

Trial sites (9)

FacilityCityRegionStatus
HCG City Cancer Center Vijayawada Andhra Pradesh Recruiting
Narayana Hrudayala Majumdar Shaw Hospital Bangalore Karnataka Recruiting
Tata Memorial Centre Mumbai Maharashtra Recruiting
Mumbai Oncocare Centre Mumbai Maharashtra Recruiting
Sahyadri Super Speciality Hospital Pune Maharashtra Recruiting
Nobel Hospital Pune Maharashtra Recruiting
Meenakshi Mission Hospital & Research Center Madurai Tamil Nadu Not Yet Recruiting
Nizams Institute of Medical Science Hyderabad Telangana Not Yet Recruiting
Health Point Hospital Kolkata West Bengal Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06189209 on ClinicalTrials.gov ↗ ← All trials in India