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

January 1, 2025 updated by: Hinova Pharmaceuticals Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HP568
In the I/II stage: HP568 administered QD or BID for 28 day cycles.
Drug: HP568
In the I/II stage: HP568 administered QD or BID for 28 day cycles.
Experimental: HP568 and palbociclib
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
In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage I: the incidence of TEAE of HP568
Time Frame: From the first administration dose to 30 calendar days after the last administration dose
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).
Time Frame: 28 days
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
Time Frame: From the first administration dose to 30 calendar days after the last administration dose
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
Time Frame: 28 days
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
Time Frame: Until all patients have completed 24 weeks administration
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)
Time Frame: Until all patients have completed 24 weeks administration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage I-III: Objective response rate (ORR)
Time Frame: Until all patients have completed study（approximately 2 years）
According to RECIST 1.1 criteria, the proportion of subjects who achieve CR (complete response)+PR (partial response).
Until all patients have completed study（approximately 2 years）
Stage I/III: 24 week clinical benefit rate (CBR)
Time Frame: Until all patients have completed 24 weeks administration
According to RECIST 1.1 criteria, the proportion of subjects who achieve confirmed complete response (CR) and/or confirmed partial response (PR) within 24 weeks plus at least 24 weeks of stable disease (SD).
Until all patients have completed 24 weeks administration
Stage I-III: Disease Control Rate (DCR)
Time Frame: Until all patients have completed study（approximately 2 years）
The proportion of subjects who achieve response and disease stability (i.e. CR+PR+SD) after treatment.
Until all patients have completed study（approximately 2 years）
Stage I-III: Progression free survival (PFS)
Time Frame: Until all patients have completed study（approximately 2 years）
from the start of treatment until tumor progression or death from any cause, which comes first.
Until all patients have completed study（approximately 2 years）
Stage I-III: Duration of response(DOR)
Time Frame: Until all patients have completed study（approximately 2 years）
the time from the first onset of response (CR or PR) to disease progression
Until all patients have completed study（approximately 2 years）
Stage I-III: Time to Response (TTR)
Time Frame: Until all patients have completed study（approximately 2 years）
The time from the start of treatment to the first recorded achievement of response (CR or PR).
Until all patients have completed study（approximately 2 years）
Stage I-II：Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)
Time Frame: on the first day of cycle 1 and cycle 2（each cycle is 28 days）
Concentration-time curve (AUC) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
on the first day of cycle 1 and cycle 2（each cycle is 28 days）
Stage I-II：Assessment of pharmacokinetic parameter maximum concentration (Cmax)
Time Frame: on the first day of cycle 1 and cycle 2（each cycle is 28 days）
Maximum concentration (Cmax) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
on the first day of cycle 1 and cycle 2（each cycle is 28 days）
Stage I-II: Assessment of pharmacokinetic parameter minimum concentration (Cmin).
Time Frame: on the first day of cycle 1 and cycle 2 (each cycle is 28 days)
minimum concentration (Cmin) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
on the first day of cycle 1 and cycle 2 (each cycle is 28 days)
Stage I-II：Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Time Frame: on the first day of cycle 1 and cycle 2 (each cycle is 28 days)
Time to maximum concentration (Tmax) for HP568 will be assessed after a single dose and after multiple doses.
on the first day of cycle 1 and cycle 2 (each cycle is 28 days)
Stage III：Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)
Time Frame: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Concentration-time curve (AUC) of HP568 and palbociclib will be assessed after single and multiple doses.
on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Stage III: Assessment of pharmacokinetic parameter maximum concentration (Cmax)
Time Frame: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
maximum concentration (Cmax) of HP568 and palbociclib will be assessed after a single dose and after multiple doses
on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Stage III: Assessment of pharmacokinetic parameter minimum concentration (Cmin)
Time Frame: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Minimum concentration (Cmin) of HP568 and palbociclib will be assessed after a single dose and after multiple doses.
on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Stage III: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Time Frame: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Time to maximum concentration (Tmax) of HP568 and palbociclib will be assessed after a single dose and after multiple doses.
on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hinova Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 7, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

November 27, 2026

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP568-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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