Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)

Launched by RHIZEN PHARMACEUTICALS SA · Dec 19, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called tenalisib for women with metastatic triple-negative breast cancer (TNBC), which means the cancer has spread beyond the breast and is harder to treat. The trial aims to find out how effective and safe tenalisib is for patients who have already received at least one but no more than three previous treatments for their cancer. It is currently looking for participants aged between 65 and 74 who have a confirmed diagnosis of TNBC and at least one area of cancer that can be measured.

To be eligible for this trial, participants need to have some basic health requirements, like proper functioning of their bone marrow, liver, and kidneys. They should also be in a good state of health overall, with certain performance levels. However, there are some reasons why someone might not be able to join, such as recent cancer treatments, significant surgeries, or ongoing serious health issues. Those who participate can expect to receive the new treatment and be monitored for its effects on their cancer and overall health. This trial is an important step in finding better options for treating this challenging type of breast cancer.

Gender

FEMALE

Eligibility criteria

• 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