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

Phase 2

Recruiting

• Conditions: Triple Negative Breast Cancer (TNBC)
• Interventions: Drug: Tenalisib

• Registration Number: NCT06189209
• Lead Sponsor: Rhizen Pharmaceuticals SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2024-01-03
• Study Start: 2024-03-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-10-31
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm, Open label study	Tenalisib	Single agent Tenalisib \[RP6530 (PI3k delta, gamma and SIK3 inhibitor)\]

Primary Outcome Measures

Name	Time	Method
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.
Overall Response Rate (ORR)	1 year	Overall Response is defined as sum of CR and PR.
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.
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 Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0	1 year	Number of adverse events reported by the patients
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

Trial Locations

Locations (7)

HCG City Cancer Center; 🇮🇳 Vijayawada, Andhra Pradesh, India

Sahyadri Super Speciality Hospital; 🇮🇳 Pune, Maharashtra, India

Narayana Hrudayala Majumdar Shaw Hospital; 🇮🇳 Bangalore, Karnataka, India

Tata Memorial Centre; 🇮🇳 Mumbai, Maharashtra, India

Mumbai Oncocare Centre; 🇮🇳 Mumbai, Maharashtra, India

Meenakshi Mission Hospital & Research Center; 🇮🇳 Madurai, Tamil Nadu, India

Nizams Institute of Medical Science; 🇮🇳 Hyderabad, Telangana, India