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NCT Number: NCT05628870

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

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).

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Binghe Xu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

HRS-1358

Drug

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

Primary outcomes

  1. Dose Limited Toxicities (DLTs)

    Time frame: up to 28 days

    Number of participants with dose-limiting toxicities (DLTs)

  2. Maximum tolerated dose

    Time frame: up to 28 days

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

  3. RP2D

    Time frame: Change From Baseline at 28 days

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

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

    Time frame: 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 outcomes

  1. Cmax

    Time frame: 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

  2. Tmax

    Time frame: 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

  3. AUC0-t

    Time frame: 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

  4. Cmax,ss

    Time frame: 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

  5. Tmax,ss

    Time frame: 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

  6. Cmin,ss

    Time frame: 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

  7. AUCss

    Time frame: 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

  8. Rac

    Time frame: 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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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