NCT06172322

A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer

A Phase Ib/Ⅱ Study of Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of NTQ1062 Tablets in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or metastatic HR positive/HER-2 negative breast cancer.

Conditions

• HR Positive/HER-2 Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	NTQ1062 with Fulvestrant	Drug: NTQ1062 tablet(s) ，PO，QD in cycles of 28 days (21 days on treatment followed by 7 days off treatment). Drug: Fulvestrant Injection 500mg in a 28-day cycle.

Timeline

• Start date: 2023-12-28
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2023-12-15
• Last updated: 2024-04-23

Locations

1 site across 1 country: China