Overview

A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer

Status:
Not yet recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Criteria
Inclusion Criteria:

1. Have a diagnosis of Hormone Receptor Positive(HR+), Human Epidermal Growth Factor
Receptor 2 Negative (HER2-) breast cancer.

2. Recurrent, locally advanced, unresectable or metastatic breast cancer with disease
progression following anti-estrogen therapy.

3. Prior treatment with chemotherapy regimens, No more than 2 prior chemotherapy regimens
in the metastatic setting.

4. At least one extracranial measurable lesion according to Response Evaluation Criteria
in Solid Tumors (RECIST) criteria version 1.1.

5. recovered from the acute effects of therapy with toxicity resolving to baseline or
grade 1 except for residual alopecia and peripheral neuropathy.

6. Adequate function of major organs.

Exclusion Criteria:

1. Has received or is undergoing the following treatments:

1. Currently receiving or have received any CDK4/6 inhibitors;

2. Receiving/received antitumor therapy within 14 days or 5 half-lives, before the
initial dose whichever is the longer;

3. Radiotherapy with a limited field of radiation for palliation within 14 days of
the initial dose of study drug, or received more than 30% of the bone marrow
irradiation, or large-scale radiotherapy within 28 days of the initial dose.;

4. Major surgery within 4 weeks of the initial dose of study drug;

5. Brain metastases unless asymptomatic, stable, and not requiring steroids for at
least 2 weeks prior to start of study treatment. Meningeal or brainstem
metastases. Spinal cord compression;

2. Abnormal liver and kidney functions that are known to affect drug metabolism and
excretion:

3. History of other primary malignancies.

4. Participating in other clinical studies.