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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 9
- Primary Endpoint
- Clinical Benefit Rate (CBR)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Adequate bone marrow, liver, and renal function
Exclusion Criteria
- •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
Arms & Interventions
Single arm, Open label study
Single agent Tenalisib [RP6530 (PI3k delta, gamma and SIK3 inhibitor)]
Intervention: Tenalisib (Drug)
Outcomes
Primary Outcomes
Clinical Benefit Rate (CBR)
Time Frame: 1 year
It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.
Overall Response Rate (ORR)
Time Frame: 1 year
Overall Response is defined as sum of CR and PR.
Duration of Clinical Benefit (DoCB)
Time Frame: 1 year
It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first in patients who achieve CR, PR or SD for 16 weeks or longer.
Progression Free Survival (PFS)
Time Frame: 1 year
It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.
Secondary Outcomes
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0(1 year)
- Trough plasma concentrations of tenalisib/metabolite(1 year)
- Correlation of efficacy to baseline mutational status(1 year)