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

NCT06757335 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HP568-101
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (6)

• Stage I: the incidence of TEAE of HP568

  the percentage of patients with treatment-emergent Adverse events(TEAE), TEAE will be evaluated using CTCAE 5.0 standards.

  From the first administration dose to 30 calendar days after the last administration dose

• Stage I: Incidence of dose limiting toxicity DLT, maximum tolerated dose MTD (if possible).

  First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated

  28 days

• Stage III: Evaluate safety during the dose escalation phase of combination therapy

  Adverse events will be evaluated using the CTCAE5.0 standard, and safety features will be based on the assessment of adverse events, including TEAE, laboratory indicators (blood routine, blood biochemistry, coagulation routine, blood lipids, urine routine), vital sign measurements (blood pressure, pulse, respiratory rate, and body temperature), physical examination, and 12 lead electrocardiogram.

  From the first administration dose to 30 calendar days after the last administration dose

• Stage III: Evaluate tolerance during the dose escalation phase of combination therapy

  First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated

  28 days

• Stage III: Evaluate the 24 week clinical benefit rate (CBR) during the dose escalation phase of combination therapy

  According to RECIST 1.1 criteria, the proportion of subjects who achieve confirmed CR (complete response) and/or confirmed PR (partial response) within 24 weeks plus at least 24 weeks of SD (stable disease).

  Until all patients have completed 24 weeks administration

• Stage II: 24 week clinical benefit rate (CBR)

  According to RECIST 1.1 criteria, the proportion of subjects who achieve confirmed CR (complete response) and/or confirmed PR (partial response) within 24 weeks plus at least 24 weeks of SD (stable disease).

  Until all patients have completed 24 weeks administration

Secondary Outcomes (14)

• Stage I-III: Objective response rate (ORR)

  Until all patients have completed study（approximately 2 years）

• Stage I/III: 24 week clinical benefit rate (CBR)

  Until all patients have completed 24 weeks administration

• Stage I-III: Disease Control Rate (DCR)

  Until all patients have completed study（approximately 2 years）

• Stage I-III: Progression free survival (PFS)

  Until all patients have completed study（approximately 2 years）

• Stage I-III: Duration of response(DOR)

  Until all patients have completed study（approximately 2 years）

Study Arms (2)

HP568

EXPERIMENTAL

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

Drug: HP568

HP568 and palbociclib

EXPERIMENTAL

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

Drug: HP568 in combination with palbociclib

Interventions

HP568 DRUG

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

HP568

HP568 in combination with palbociclib DRUG

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

HP568 and palbociclib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-75 years old (inclusive of both ends) at the time of signing the informed consent form.
• 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.
• Disease progression confirmed by imaging occurs during or after the last systemic anti-tumor treatment before the first medication.

You may not qualify if:

• Known or suspected allergy to any ingredient of HP568 formulation, and allergy to any ingredient of palbociclib (only applicable to stage III).
• 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.
• Previously received other ER-ROTAC drugs such as ARV-471.
• 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).

Sponsors & Collaborators

• Hinova Pharmaceuticals Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhonghua Zhou

CONTACT

+86-28-85058465; zhzhou1@hinovapharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: January 3, 2025
• Study Start: January 7, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share