Actively Recruiting
A Phase II, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer
Led by Rhizen Pharmaceuticals SA · Updated on 2025-12-02
40
Participants Needed
9
Research Sites
12 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
Researchers are evaluating the safety and effectiveness of Tenalisib in patients with metastatic triple negative breast cancer (TNBC) who have previously received one to three therapies for their metastatic disease. This Phase II, open-label, single-arm study focuses on this specific type of breast cancer, which lacks certain hormone receptors, making treatment challenging. The study is sponsored by Rhizen Pharmaceuticals SA and aims to better understand how Tenalisib works in this patient group. Participants will receive Tenalisib, a drug that inhibits PI3K delta, gamma, and SIK3, given orally at doses of 800mg and 400mg twice daily. This study involves a single treatment arm where all participants receive Tenalisib without comparison to a placebo or other drug. The treatment period is planned with close monitoring of response and side effects over the course of one year. During the study, participants will undergo regular assessments including measuring tumor response by RECIST criteria, tracking clinical benefit rate, duration of clinical benefit, overall response rate, and progression-free survival at one year. Safety will be monitored by recording treatment-related adverse events. Blood samples will be collected to measure drug and metabolite levels and to explore the relationship between genetic mutations and treatment response. Participants will be followed throughout the study until its completion in 2027.
CONDITIONS
Brief 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 with histologically confirmed triple negative breast cancer
- Patients who have received at least 1 but not more than 3 prior chemotherapy treatments in a metastatic setting
- Patients with at least one measurable lesion according to RECIST 1.1; bone-only disease is not allowed
- ECOG performance status between 0 and 2
- Adequate bone marrow, liver, and kidney function
You will not qualify if you...
- Use of cancer therapy or investigational cancer drugs within 3 weeks or 5 half-lives, whichever is shorter
- Not recovered from acute toxicities of previous therapy except for hair loss
- Prior treatment with PI3K inhibitors for breast cancer
- Major surgery within 4 weeks before starting study treatment
- Symptomatic uncontrolled brain metastases
- Ongoing immunosuppressive treatment including systemic corticosteroids
- History of severe skin reactions
- Any concurrent disease or condition that would interfere with study participation
- Pregnancy or breastfeeding
- Severe or uncontrolled medical conditions affecting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants take Tenalisib orally twice daily as a single agent to treat metastatic triple negative breast cancer.
Regular visits throughout treatment as per protocol
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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