Breast CancerPhase 1/2NCT06757335
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
A Phase 1/2 study testing HP568 and HP568 in combination with palbociclib in people with Breast Cancer, run by Hinova Pharmaceuticals Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HP568 and HP568 in combination with palbociclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2025to 27 Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- HP568, HP568 in combination with palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HP568Drug
In the I/II stage: HP568 administered QD or BID for 28 day cycles.
HP568 in combination with palbociclibDrug
In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| HP568 | Experimental | In the I/II stage: HP568 administered QD or BID for 28 day cycles. Receives: 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. Receives: Drug: HP568 in combination with palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: Until all patients have completed 24 weeks administration
Secondary outcomes (14)
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).
Measured: Until all patients have completed study（approximately 2 years）
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).
Measured: Until all patients have completed 24 weeks administration
Stage I-III: Disease Control Rate (DCR)
The proportion of subjects who achieve response and disease stability (i.e. CR+PR+SD) after treatment.
Measured: Until all patients have completed study（approximately 2 years）
Stage I-III: Progression free survival (PFS)
from the start of treatment until tumor progression or death from any cause, which comes first.
Measured: Until all patients have completed study（approximately 2 years）
Stage I-III: Duration of response(DOR)
the time from the first onset of response (CR or PR) to disease progression
Measured: Until all patients have completed study（approximately 2 years）
Stage I-III: Time to Response (TTR)
The time from the start of treatment to the first recorded achievement of response (CR or PR).
Measured: Until all patients have completed study（approximately 2 years）
Stage I-II：Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)
Concentration-time curve (AUC) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
Measured: 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)
Maximum concentration (Cmax) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
Measured: 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).
minimum concentration (Cmin) for single and multiple dose of HP568 will be assessed after a single dose and after multiple doses.
Measured: 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 to maximum concentration (Tmax) for HP568 will be assessed after a single dose and after multiple doses.
Measured: 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)
Concentration-time curve (AUC) of HP568 and palbociclib will be assessed after single and multiple doses.
Measured: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Stage III: Assessment of pharmacokinetic parameter maximum concentration (Cmax)
maximum concentration (Cmax) of HP568 and palbociclib will be assessed after a single dose and after multiple doses
Measured: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Stage III: Assessment of pharmacokinetic parameter minimum concentration (Cmin)
Minimum concentration (Cmin) of HP568 and palbociclib will be assessed after a single dose and after multiple doses.
Measured: 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 to maximum concentration (Tmax) of HP568 and palbociclib will be assessed after a single dose and after multiple doses.
Measured: on the Day 1 and Day 21 of cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion27 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hinova Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757335
- Sponsor's protocol ID
- HP568-101
- Status last verified
- Oct 2024
- First submitted
- 7 Nov 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06757335
- Acronym / sponsor ID
- HP568-101
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Hinova Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 27 Nov 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HP568 | Experimental | Drug: HP568In the I/II stage: HP568 administered QD or BID for 28 day cycles. |
| HP568 and palbociclib | Experimental | Drug: HP568 in combination with palbociclibIn the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HP568In the I/II stage: HP568 administered QD or BID for 28 day cycles. | Drug | HP568 |
| HP568 in combination with palbociclibIn the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days. | Drug | HP568 and palbociclib |
Primary outcome
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.
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
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.
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
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).
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).
14 secondary outcomes
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HP568 and HP568 in combination with palbociclib in people with Breast Cancer, run by Hinova Pharmaceuticals Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhonghua Zhou (+86-28-85058465, zhzhou1@hinovapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.