Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
NCT ID: NCT06189209
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-03-04
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm, Open label study
Single agent Tenalisib \[RP6530 (PI3k delta, gamma and SIK3 inhibitor)\]
Tenalisib
Tenalisib will be administered 800mg/ 400mg BID, orally
Interventions
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Tenalisib
Tenalisib will be administered 800mg/ 400mg BID, orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Incozen Therapeutics Pvt Ltd
UNKNOWN
Rhizen Pharmaceuticals SA
INDUSTRY
Responsible Party
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Locations
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HCG City Cancer Center
Vijayawada, Andhra Pradesh, India
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, India
Tata Memorial Centre
Mumbai, Maharashtra, India
Mumbai Oncocare Centre
Mumbai, Maharashtra, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, India
Nobel Hospital
Pune, Maharashtra, India
Meenakshi Mission Hospital & Research Center
Madurai, Tamil Nadu, India
Nizams Institute of Medical Science
Hyderabad, Telangana, India
Health Point Hospital
Kolkata, West Bengal, India
Countries
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Central Contacts
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Facility Contacts
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Dr. Priyadarshini Lakshmi
Role: primary
Dr. Nidhi Tandon
Role: primary
Dr. Sudeep Gupta
Role: primary
Dr. Ashish Joshi
Role: primary
Dr. Tushar Patil
Role: primary
Dr. Minish Mahendra Jain
Role: primary
Dr. Saju SV
Role: primary
Dr. Sadashivudu Gundeti
Role: primary
Dr. Suparna Kanti Pal
Role: primary
Other Identifiers
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RP6530-2301
Identifier Type: -
Identifier Source: org_study_id
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