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

NCT ID: NCT06757335

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2026-11-27

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HP568

In the I/II stage: HP568 administered QD or BID for 28 day cycles.

Group Type: EXPERIMENTAL

HP568

Intervention Type: DRUG

In the I/II stage: HP568 administered QD or BID for 28 day cycles.

HP568 and palbociclib

In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

Group Type: EXPERIMENTAL

HP568 in combination with palbociclib

Intervention Type: DRUG

In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

Interventions

HP568

In the I/II stage: HP568 administered QD or BID for 28 day cycles.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Women aged 18-75 years old (inclusive of both ends) at the time of signing the informed consent form.

2. Patients with locally advanced inoperable or recurrent or metastatic breast cancer ER+/HER2- advanced breast cancer is confirmed by histopathology have confirmed that the primary and/or metastatic lesion.

3. Previously received at least 1-line endocrine therapy (endocrine therapy duration ≥ 6 months) and ≤ 2-line chemotherapy (≤ 2-line chemotherapy limited to dose escalation stage) for the recurrence or metastasis stage of the disease. The third stage : Inclusion of patients who have not received prior treatment but are suitable for CDK4/6i therapy.

4. Disease progression confirmed by imaging occurs during or after the last systemic anti-tumor treatment before the first medication.

Exclusion Criteria

1. Known or suspected allergy to any ingredient of HP568 formulation, and allergy to any ingredient of palbociclib (only applicable to stage III).

2. Within 42 days prior to the first administration, Fluvistran was used; Other endocrine therapies such as tamoxifen, toremifene, letrozole, anastrozole, and exemestane were used within 14 days prior to the first administration.

3. Previously received other ER-ROTAC drugs such as ARV-471.

4. Within 6 weeks before the first administration of HP568 in this study, nitrosoureas or mitomycin were used; Received any anti-tumor treatment, including immunotherapy, chemotherapy, radiotherapy, or targeted therapy, within 28 days prior to the first administration (or of the drug's 5 half lives,take the shorter one).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hinova Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhonghua Zhou

Role: CONTACT

zhzhou1@hinovapharma.com

+86-28-85058465

Other Identifiers

HP568-101

Identifier Type: -

Identifier Source: org_study_id