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)

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 Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer (TNBC)
• Intervention / Treatment: Drug: Tenalisib

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Prajak Barde, MD; Phone Number: +41325800175; Email: pjb@rhizen.com

Study Locations

• India
  • Andhra Pradesh
    • Vijayawada, Andhra Pradesh, India, 520002
      • Recruiting
      • HCG City Cancer Center
      • Contact: Dr. Priyadarshini Lakshmi
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Recruiting
      • Narayana Hrudayala Majumdar Shaw Hospital
      • Contact: Dr. Nidhi Tandon
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Recruiting
      • Tata Memorial Centre
      • Contact: Dr. Sudeep Gupta
    • Mumbai, Maharashtra, India, 400056
      • Recruiting
      • Mumbai Oncocare Centre
      • Contact: Dr. Ashish Joshi
    • Pune, Maharashtra, India, 411004
      • Recruiting
      • Sahyadri Super Speciality Hospital
      • Contact: Dr. Tushar Patil
    • Pune, Maharashtra, India, 411013
      • Recruiting
      • Nobel Hospital
      • Contact: Dr. Minish Mahendra Jain
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625107
      • Not yet recruiting
      • Meenakshi Mission Hospital & Research Center
      • Contact: Dr. Saju SV
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Not yet recruiting
      • Nizams Institute of Medical Science
      • Contact: Dr. Sadashivudu Gundeti
  • West Bengal
    • Kolkata, West Bengal, India, 700025
      • Recruiting
      • Health Point Hospital
      • Contact: Dr. Suparna Kanti Pal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm, Open label study; Single agent Tenalisib [RP6530 (PI3k delta, gamma and SIK3 inhibitor)]	Drug: Tenalisib; Tenalisib will be administered 800mg/ 400mg BID, orally; Other Names: RP6530

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

• Sponsor: Rhizen Pharmaceuticals SA
• Collaborators: Incozen Therapeutics Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Tenalisib; RP6530
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Phosphoinositide-3 Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; tenalisib
• Other Study ID Numbers: RP6530-2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No