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

Hinova Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Drug: HP568 in combination with palbociclib; Drug: HP568

Study type: Interventional

Funder types: Industry

Identifiers

NCT06757335

HP568-101

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

HP568

Experimental group

Description:

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

Treatment:

Drug: HP568

HP568 and palbociclib

Experimental group

Description:

In the III stage: Daily oral dosages of HP568 for 28 days in combination with palbociclib for 21 days.

Treatment:

Drug: HP568 in combination with palbociclib