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

Shandong Suncadia Medicine Co., Ltd.102 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Breast Cancer

Interventions

HRS-1358DRUG

HRS-1358 or combination with Dalpiciclib Isethionate Tablets will be administered daily orally in continuous dosing over 28-day cycles.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Dose Limited Toxicities (DLTs)

Number of participants with dose-limiting toxicities (DLTs)

Time frame: up to 28 days

Maximum tolerated dose

The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets

Time frame: up to 28 days

RP2D

select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets

Time frame: Change From Baseline at 28 days

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time frame: up to 30 days after the last dose

Secondary Outcomes

Cmax

PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets

Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

Tmax

PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets

Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

AUC0-t

PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets

Time frame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

Central Contacts

Xia Zhang

CONTACT

+0518-81220121 Xia.zhang@hengrui.com

Data from ClinicalTrials.gov

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