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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06189209

Enrollment

Registered

2024-01-03

Start date

2024-03-04

Completion date

2027-03-31

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple Negative Breast Cancer (TNBC)

Keywords

RP6530, Tenalisib

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.

Interventions

DRUGTenalisib

Tenalisib will be administered 800mg/ 400mg BID, orally

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Benefit Rate (CBR)	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.
Duration of Clinical Benefit (DoCB)	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.
Overall Response Rate (ORR)	1 year	Overall Response is defined as sum of CR and PR.
Progression Free Survival (PFS)	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

Measure	Time frame	Description
Trough plasma concentrations of tenalisib/metabolite	1 year	plasma concentrations of drug
Correlation of efficacy to baseline mutational status	1 year	Baseline mutational status and its correlation with efficacy
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0	1 year	Number of adverse events reported by the patients

Countries

India

Contacts

Primary ContactPrajak Barde, MD

pjb@rhizen.com+41325800175

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026