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

NCT06189209 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RP6530-2301
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

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.

Conditions

Triple Negative Breast Cancer (TNBC)

Keywords

RP6530; Tenalisib

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (1)

Single arm, Open label study

EXPERIMENTAL

Single agent Tenalisib \[RP6530 (PI3k delta, gamma and SIK3 inhibitor)\]

Drug: Tenalisib

Interventions

Tenalisib DRUG

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

Also known as: RP6530

Single arm, Open label study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2.
• Adequate bone marrow, liver, and renal function

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead
• Incozen Therapeutics Pvt Ltd: collaborator

Study Sites (9)

HCG City Cancer Center

Vijayawada, Andhra Pradesh, 520002, India

RECRUITING

Narayana Hrudayala Majumdar Shaw Hospital

Bangalore, Karnataka, 560099, India

RECRUITING

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

Mumbai Oncocare Centre

Mumbai, Maharashtra, 400056, India

RECRUITING

Sahyadri Super Speciality Hospital

Pune, Maharashtra, 411004, India

RECRUITING

Nobel Hospital

Pune, Maharashtra, 411013, India

RECRUITING

Meenakshi Mission Hospital & Research Center

Madurai, Tamil Nadu, 625107, India

NOT YET RECRUITING

Nizams Institute of Medical Science

Hyderabad, Telangana, 500082, India

NOT YET RECRUITING

Health Point Hospital

Kolkata, West Bengal, 700025, India

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

tenalisib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Prajak Barde, MD

CONTACT

+41325800175; pjb@rhizen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 3, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)