Triple Negative Breast Cancer (TNBC)Phase 2NCT06189209
Efficacy and Safety of Tenalisib in Patients With Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 2 study testing Tenalisib in people with Triple Negative Breast Cancer (TNBC), run by Rhizen Pharmaceuticals SA at 9 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Tenalisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesIndia
- Study dates
- 4 Mar 2024to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
India9 sites, 9 recruiting
- Recruiting
Narayana Hrudayala Majumdar Shaw Hospital
Bangalore, Karnataka, 560099
Dr. Nidhi Tandon
- Not yet recruiting
Nizams Institute of Medical Science
Hyderabad, Telangana, 500082
Dr. Sadashivudu Gundeti
- Recruiting
Health Point Hospital
Kolkata, West Bengal, 700025
Dr. Suparna Kanti Pal
- Not yet recruiting
Meenakshi Mission Hospital & Research Center
Madurai, Tamil Nadu, 625107
Dr. Saju SV
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Dr. Sudeep Gupta
- Recruiting
Mumbai Oncocare Centre
Mumbai, Maharashtra, 400056
Dr. Ashish Joshi
- Recruiting
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004
Dr. Tushar Patil
- Recruiting
Nobel Hospital
Pune, Maharashtra, 411013
Dr. Minish Mahendra Jain
- Recruiting
HCG City Cancer Center
Vijayawada, Andhra Pradesh, 520002
Dr. Priyadarshini Lakshmi
About this study
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)
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)
- Being tested
- Tenalisib
- Keywords
- RP6530, Tenalisib
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenalisibDrug
Also called RP6530
Tenalisib will be administered 800mg/ 400mg BID, orally
| Study group | Role | What they receive |
|---|---|---|
| Single arm, Open label study | Experimental | Single agent Tenalisib [RP6530 (PI3k delta, gamma and SIK3 inhibitor)] Receives: Drug: Tenalisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Overall Response Rate (ORR)
Overall Response is defined as sum of CR and PR.
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Number of adverse events reported by the patients
Measured: 1 year
Trough plasma concentrations of tenalisib/metabolite
plasma concentrations of drug
Measured: 1 year
Correlation of efficacy to baseline mutational status
Baseline mutational status and its correlation with efficacy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start4 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incozen Therapeutics Pvt Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189209
- Sponsor's protocol ID
- RP6530-2301
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2023
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06189209
- Acronym / sponsor ID
- RP6530-2301
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Keywords
- RP6530, Tenalisib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Collaborators
- Incozen Therapeutics Pvt Ltd
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm, Open label study | Experimental | Drug: TenalisibSingle agent Tenalisib [RP6530 (PI3k delta, gamma and SIK3 inhibitor)] |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenalisibAlso: RP6530Tenalisib will be administered 800mg/ 400mg BID, orally | Drug | Single arm, Open label study |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: 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)
Time frame: 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)
Time frame: 1 year
Overall Response is defined as sum of CR and PR.
Progression Free Survival (PFS)
Time frame: 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.
3 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: 1 year
Trough plasma concentrations of tenalisib/metabolite
Time frame: 1 year
Correlation of efficacy to baseline mutational status
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenalisib in people with Triple Negative Breast Cancer (TNBC), run by Rhizen Pharmaceuticals SA at 9 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prajak Barde, MD (+41325800175, pjb@rhizen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.