Not yet recruiting NCT06757335
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HP568, HP568 in combination with palbociclib.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug HP568
In the I/II stage: HP568 administered QD or BID for 28 day cycles. - 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.
Primary outcome measures
- Stage I: the incidence of TEAE of HP568 [Time frame: 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]
- 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]
- Stage III: Evaluate tolerance during the dose escalation phase of combination therapy [Time frame: 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]
- Stage II: 24 week clinical benefit rate (CBR) [Time frame: Until all patients have completed 24 weeks administration]
Secondary outcome measures (12)
- Stage I-III: Objective response rate (ORR) [Time frame: 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]
- Stage I-III: Disease Control Rate (DCR) [Time frame: 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）]
- Stage I-III: Duration of response(DOR) [Time frame: 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）]
- 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）]
- 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）]
- 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)]
- 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)]
- 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)]
- 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)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06757335 · HP568-101