Recruiting
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
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.
ClinicalTrials.gov IDNCT06189209
PhasePHASE2
Enrollment40
SponsorRhizen Pharmaceuticals SA
Age18 Years
SexFEMALE
Conditions studied
Triple Negative Breast Cancer (TNBC)
About this study
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.
Interventions
- Drug: Tenalisib — Tenalisib will be administered 800mg/ 400mg BID, orally
Primary outcomes
- Clinical Benefit Rate (CBR) (1 year)
- Duration of Clinical Benefit (DoCB) (1 year)
- Overall Response Rate (ORR) (1 year)
- Progression Free Survival (PFS) (1 year)
Eligibility information
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
Study locations
- HCG City Cancer Center, Vijayawada, Andhra Pradesh 520002 India
- Narayana Hrudayala Majumdar Shaw Hospital, Bangalore, Karnataka 560099 India
- Tata Memorial Centre, Mumbai, Maharashtra 400012 India
- Mumbai Oncocare Centre, Mumbai, Maharashtra 400056 India
- Sahyadri Super Speciality Hospital, Pune, Maharashtra 411004 India
- Nobel Hospital, Pune, Maharashtra 411013 India
- Meenakshi Mission Hospital & Research Center, Madurai, Tamil Nadu 625107 India
- Nizams Institute of Medical Science, Hyderabad, Telangana 500082 India
- Health Point Hospital, Kolkata, West Bengal 700025 India
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.