Evaluating Tenalisib for Metastatic Triple Negative Breast Cancer

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)

This study is testing a new drug called tenalisib to see if it can help people with metastatic triple negative breast cancer who have already tried other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Rhizen Pharmaceuticals SA (industry)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Vijayawada, Andhra Pradesh and 8 other locations)
• Trial ID: NCT06189209 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, single-arm study aims to assess the efficacy and safety of tenalisib in patients diagnosed with metastatic triple negative breast cancer (TNBC). Eligible participants must have received between one and three prior therapies in a metastatic setting and have at least one measurable lesion. The study will monitor the treatment's effectiveness and safety profile in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with histologically confirmed metastatic TNBC who have undergone one to three prior chemotherapy regimens.

Not a fit: Patients with symptomatic uncontrolled brain metastasis or those who have previously been treated with PI3K inhibitors for breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic TNBC who have limited treatment choices.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies targeting TNBC with novel therapies have shown promise, indicating potential for success.

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

Where this trial is running

Vijayawada, Andhra Pradesh and 8 other locations

• HCG City Cancer Center — Vijayawada, Andhra Pradesh, India (RECRUITING)
• Narayana Hrudayala Majumdar Shaw Hospital — Bangalore, Karnataka, India (RECRUITING)
• Tata Memorial Centre — Mumbai, Maharashtra, India (RECRUITING)
• Mumbai Oncocare Centre — Mumbai, Maharashtra, India (RECRUITING)
• Sahyadri Super Speciality Hospital — Pune, Maharashtra, India (RECRUITING)
• Nobel Hospital — Pune, Maharashtra, India (RECRUITING)
• Meenakshi Mission Hospital & Research Center — Madurai, Tamil Nadu, India (NOT_YET_RECRUITING)
• Nizams Institute of Medical Science — Hyderabad, Telangana, India (NOT_YET_RECRUITING)
• Health Point Hospital — Kolkata, West Bengal, India (RECRUITING)

Study contacts

• Study coordinator: Prajak Barde, MD

Conditions: Triple Negative Breast Cancer, RP6530, Tenalisib