NCT06757335

A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer

A Multicenter, Open, Dose Escalation/dose Escalation, and Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral HP568 Tablets Alone and in Combination with Palbociclib in Patients with ER+/HER2 Advanced Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Hinova Pharmaceuticals Inc. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or metastatic breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	HP568	In the I/II stage: HP568 administered QD or BID for 28 day cycles.
DRUG	HP568 in combination with palbociclib	In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-01-31
• Completion: 2026-11-27
• First posted: 2025-01-03
• Last updated: 2025-01-03

Regulatory

• FDA-regulated drug study