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

NCT06189209 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-02

No results posted yet for this study

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)

Interventions

DRUG

Tenalisib

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

Sponsors & Collaborators

  • Incozen Therapeutics Pvt Ltd

    collaborator UNKNOWN

  • Rhizen Pharmaceuticals SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-12-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189209 on ClinicalTrials.gov