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.
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.
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).
Sequential
HP568
DrugIn the I/II stage: HP568 administered QD or BID for 28 day cycles.
HP568 in combination with palbociclib
DrugIn the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.
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.
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
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.
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
Stage I-III: Objective response rate (ORR)
According to RECIST 1.1 criteria, the proportion of subjects who achieve CR (complete response)+PR (partial response).
Stage I/III: 24 week clinical benefit rate (CBR)
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).
Stage I-III: Disease Control Rate (DCR)
The proportion of subjects who achieve response and disease stability (i.e. CR+PR+SD) after treatment.
Stage I-III: Progression free survival (PFS)
from the start of treatment until tumor progression or death from any cause, which comes first.
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This trial is not recruiting at the moment. You can still explore other options:
