Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer (NCT04631835) | Clinical Trial Compass
UnknownPhase 1
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
China54 participantsStarted 2020-09-08
Plain-language summary
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell growth. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-10352 at single dose and multiple doses.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men or women aged more than or equal to (≥) 18 years, and less than (\<) 75 years.
✓. HR+ HER2- locally advanced or metastatic breast cancer patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable.
✓. Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
✓. ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks.
✓. Estimated life expectancy greater than (\>) three months.
✓. Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential.
✓. Sign Informed Consent Form.
Exclusion criteria
✕. Treatment with any of the following:
✕. Previous or current treatment with PI3K, AKT or mTOR inhibitors.
✕. Any cytotoxic chemotherapy, investigational agents within 21 days of the first dose of study drug; anticancer drugs which have been received within 14 days before the first administration.
What they're measuring
1
Number of subjects with any dose limiting toxicity (DLT)
Timeframe: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
2
To determine the maximum tolerated dose (MTD)
Timeframe: From the single dose to the last dose of the first cycle defined as 28 days of multiple dosing (35 days).
. Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
✕. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
✕. Inadequate bone marrow reserve or organ function.
✕. Uncontrolled pleural effusion or ascites or pericardial effusion.
✕. Known and untreated, or active central nervous system metastases.