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

Phase 2Not Yet RecruitingNCT06757335

Hinova Pharmaceuticals Inc.204 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Breast Cancer

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

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).

First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated

Time frame: 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.

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

First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated

Time frame: 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).

Time frame: Until all patients have completed 24 weeks administration

Stage II: 24 week clinical benefit rate (CBR)

Central Contacts

Zhonghua Zhou

CONTACT

+86-28-85058465 zhzhou1@hinovapharma.com

Data from ClinicalTrials.gov

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Secondary Outcomes

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).