Actively Recruiting
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Led by Rhizen Pharmaceuticals SA · Updated on 2025-12-02
40
Participants Needed
9
Research Sites
160 weeks
Total Duration
On this page
Sponsors
R
Rhizen Pharmaceuticals SA
Lead Sponsor
I
Incozen Therapeutics Pvt Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Cancer therapy or 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
HCG City Cancer Center
Vijayawada, Andhra Pradesh, India, 520002
Actively Recruiting
2
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, India, 560099
Actively Recruiting
3
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Actively Recruiting
4
Mumbai Oncocare Centre
Mumbai, Maharashtra, India, 400056
Actively Recruiting
5
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India, 411004
Actively Recruiting
6
Nobel Hospital
Pune, Maharashtra, India, 411013
Actively Recruiting
7
Meenakshi Mission Hospital & Research Center
Madurai, Tamil Nadu, India, 625107
Not Yet Recruiting
8
Nizams Institute of Medical Science
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
9
Health Point Hospital
Kolkata, West Bengal, India, 700025
Actively Recruiting
Research Team
P
Prajak Barde, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here