A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 1

Conditions: Breast Cancer

Treatments: Drug: HRS-1358

Study type: Interventional

Funder types: Industry

Identifiers

NCT05628870

HRS-1358-I-101

Details and patient eligibility

About

The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).

Enrollment: 102 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically diagnosis of local advanced or metastatic breast cancer
2. Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
3. At least 1 line of endocrine therapy in the metastatic or advanced setting
4. ECOG performance status score: 0-1;
5. Adequate organ functions as defined
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion criteria

1. the investigators judged that it was not suitable to endocrine therapy
2. patients with active brain metastasis (without medical control or with clinical symptoms),
3. History of clinically significant cardiovascular or cerebrovascular diseases
4. The subject has one of many factors affecting oral 、absorption, distribution, metabolism and excretion of drugs
5. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation
6. Have received other similar drugs in the past;
7. Known history of allergy to HRS-1358 ingredients

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

HRS-1358

Experimental group

Description:

Daily oral dosages of HR-1358； Daily oral dosages of HR-1358 and Dalpiciclib Isethionate Tablets

Treatment:

Drug: HRS-1358