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

Breast Cancer Clinical Trial

Official title:

A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy in Patients With Metastatic or Locally Advanced Breast Cancer.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05628870
• Other study ID #: HRS-1358-I-101
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: February 7, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2022
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 102
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• HRS-1358
HRS-1358 will be administered daily orally in continuous dosing over 28-day cycles.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limited Toxicities (DLTs)	Number of participants with dose-limiting toxicities (DLTs)	up to 28 days
Primary	Maximum tolerated dose	The Maximum tolerated dose of HRS-1358 monotherapy	up to 28 days
Primary	RP2D	select the Recommended Phase 2 Dose (RP2D) of HRS-1358	Change From Baseline at 28 days
Primary	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	up to 30 days after the last dose
Secondary	Cmax	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Tmax	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	AUC0-t	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Cmax,ss	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Tmax,ss	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Cmin,ss	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	AUCss	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Rac	PK parameters of multiple doses of HRS-1358 monotherapy	0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period
Secondary	Overall response rate (ORR) in participants		Up to approximately 1 year
Secondary	Clinical benefit rate (CBR) in participants		Up to approximately 1 year
Secondary	Duration of response (DOR) in participants		Up to approximately 1 year
Secondary	Progression Free Survival (PFS) observed in participants		Up to approximately 1 year