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RecruitingNCT05628870Updated Mar 17, 2025

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

A Phase 1 interventional study of HRS-1358 in Breast Cancer, sponsored by Shandong Suncadia Medicine Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 102 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    HRS-1358

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

    Drug: HRS-1358

Interventions

  • DrugHRS-1358

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

06

What researchers measure

Primary outcomes

  1. Dose Limited Toxicities (DLTs)

    Number of participants with dose-limiting toxicities (DLTs)

    Time frame: up to 28 days

  2. Maximum tolerated dose

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

    Time frame: up to 28 days

  3. 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

  4. 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

  1. 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

  2. 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

  3. 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

  4. Cmax,ss

    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

  5. Tmax,ss

    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

  6. Cmin,ss

    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

  7. AUCss

    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

  8. Rac

    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

  9. Overall response rate (ORR) in participants

    Time frame: Up to approximately 1 year

  10. Clinical benefit rate (CBR) in participants

    Time frame: Up to approximately 1 year

  11. Duration of response (DOR) in participants

    Time frame: Up to approximately 1 year

  12. Progression Free Survival (PFS) observed in participants

    Time frame: Up to approximately 1 year

07

Study locations

1 of 1 sites recruiting
  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Beijing 100021, China
    • Binghe Xu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05628870
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Nov 29, 2022
Start date
Feb 7, 2023
Primary completion
Jun 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 17, 2025

Study contacts

Xia Zhang
Contact
Xia.zhang@hengrui.com
+0518-81220121

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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