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NCT Number: NCT06757335

A Phase I/II Trial to Evaluate Oral HP568 Tablets 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

HP568

Drug

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

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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).

  6. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhonghua Zhou

CONTACT

[email protected]

+86-28-85058465

Sponsors and collaborators

Lead sponsor

Hinova Pharmaceuticals Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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