Status:
RECRUITING
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Lead Sponsor:
Rhizen Pharmaceuticals SA
Collaborating Sponsors:
Incozen Therapeutics Pvt Ltd
Conditions:
Triple Negative Breast Cancer (TNBC)
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06189209
Start Date
March 4 2024
End Date
March 31 2027
Last Update
December 2 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
HCG City Cancer Center
Vijayawada, Andhra Pradesh, India, 520002
2
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, India, 560099
3
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
4
Mumbai Oncocare Centre
Mumbai, Maharashtra, India, 400056