RecruitingPhase 2NCT06189209
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
A Phase II, Multi-center, Single-arm, Open-label Study to Assess the Efficacy and Safety of Tenalisib, a PI3K δ/γ, and SIK3 Inhibitor, in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Sponsor
Rhizen Pharmaceuticals SA
Enrollment
40 participants
Start Date
Mar 4, 2024
Study Type
INTERVENTIONAL
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 therapies in a metastatic setting.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria5
- 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 Criteria10
- 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
Interventions
DRUGTenalisib
Tenalisib will be administered 800mg/ 400mg BID, orally
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06189209