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

Triple Negative Breast Cancer (TNBC) Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06189209
• Other study ID #: RP6530-2301
• Status: Recruiting
• Phase: Phase 2
• Start date: March 4, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Rhizen Pharmaceuticals SA
• Contact: Prajak Barde, MD
• Phone: +41325800175
• Email: pjb[@]rhizen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer (TNBC)
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Tenalisib
Tenalisib will be administered 800mg BID, orally

Locations

Country	Name	City	State
India	Narayana Hrudayala Majumdar Shaw Hospital	Bangalore	Karnataka
India	Nizams Institute of Medical Science	Hyderabad	Telangana
India	Meenakshi Mission Hospital & Research Center	Madurai	Tamil Nadu
India	Mumbai Oncocare Centre	Mumbai	Maharashtra
India	Tata Memorial Centre	Mumbai	Maharashtra
India	Sahyadri Super Speciality Hospital	Pune	Maharashtra
India	HCG City Cancer Center	Vijayawada	Andhra Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Rhizen Pharmaceuticals SA	Incozen Therapeutics Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Benefit Rate (CBR)	It is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) for 16 weeks or longer.	1 year
Primary	Duration of Clinical Benefit (DoCB)	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.	1 year
Primary	Overall Response Rate (ORR)	Overall Response is defined as sum of CR and PR.	1 year
Primary	Progression Free Survival (PFS)	It is defined as the time from the first dose to disease progression or death on study from any cause, whichever occurs first.	1 year
Secondary	Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0	Number of adverse events reported by the patients	1 year
Secondary	Trough plasma concentrations of tenalisib/metabolite	plasma concentrations of drug	1 year
Secondary	Correlation of efficacy to baseline mutational status	Baseline mutational status and its correlation with efficacy	1 year