NCT06189209

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tenalisib	Tenalisib will be administered 800mg/ 400mg BID, orally

Timeline

• Start date: 2024-03-04
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2024-01-03
• Last updated: 2025-12-02

Locations

9 sites across 1 country: India

Regulatory

• FDA-regulated drug study