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

Phase 1

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: HRS-1358

• Registration Number: NCT05628870
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-29
• Study Start: 2023-02-07
• Status Verified: 2024-08
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-06
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRS-1358	HRS-1358	Daily oral dosages of HR-1358； Daily oral dosages of HR-1358 and Dalpiciclib Isethionate Tablets

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	up to 28 days	The Maximum tolerated dose of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Dose Limited Toxicities (DLTs)	up to 28 days	Number of participants with dose-limiting toxicities (DLTs)
RP2D	Change From Baseline at 28 days	select the Recommended Phase 2 Dose (RP2D) of HRS-1358 or combination with Dalpiciclib Isethionate Tablets
Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)	up to 30 days after the last dose	Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcome Measures

Name	Time	Method
Tmax	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Cmax	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Rac	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Duration of response (DOR) in participants	Up to approximately 1 year
AUC0-t	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Tmax,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Overall response rate (ORR) in participants	Up to approximately 1 year
Clinical benefit rate (CBR) in participants	Up to approximately 1 year
Progression Free Survival (PFS) observed in participants	Up to approximately 1 year
Cmax,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
Cmin,ss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets
AUCss	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period	PK parameters of multiple doses of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China