Clinical trial NCT06189209: Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Triple Negative Breast Cancer (TNBC)
Keywords: RP6530
Tenalisib
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
Collaborators: name: Incozen Therapeutics Pvt Ltd
First posted: 2024-01-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Clinical Benefit Rate (CBR)
timeFrame: 1 year
measure: Duration of Clinical Benefit (DoCB)
timeFrame: 1 year
measure: Overall Response Rate (ORR)
timeFrame: 1 year
measure: Progression Free Survival (PFS)
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
timeFrame: 1 year
measure: Trough plasma concentrations of tenalisib/metabolite
timeFrame: 1 year
measure: Correlation of efficacy to baseline mutational status
timeFrame: 1 year
Other outcomes:
Locations:
city: Vijayawada
country: India
facility: HCG City Cancer Center
state: Andhra Pradesh
city: Bangalore
country: India
facility: Narayana Hrudayala Majumdar Shaw Hospital
state: Karnataka
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
city: Mumbai
country: India
facility: Mumbai Oncocare Centre
state: Maharashtra
city: Pune
country: India
facility: Sahyadri Super Speciality Hospital
state: Maharashtra
city: Madurai
country: India
facility: Meenakshi Mission Hospital & Research Center
state: Tamil Nadu
city: Hyderabad
country: India
facility: Nizams Institute of Medical Science
state: Telangana
Study officials:
References: