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

NCT05628870 | Recruiting Phase 1

• 1 other identifier: HRS-1358-I-101
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Dose Limited Toxicities (DLTs)

  Number of participants with dose-limiting toxicities (DLTs)

  up to 28 days

• Maximum tolerated dose

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

  up to 28 days

• RP2D

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

  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

  up to 30 days after the last dose

Secondary Outcomes (12)

• Cmax

  0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

• Tmax

  0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

• AUC0-t

  0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

• Cmax,ss

  0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

• Tmax,ss

  0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fourth treatment period

Study Arms (1)

HRS-1358

EXPERIMENTAL

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

Drug: HRS-1358

Interventions

HRS-1358 DRUG

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

HRS-1358

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xia Zhang

CONTACT

+0518-81220121; Xia.zhang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm study of HRS-1358

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: February 7, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-08

Locations

CN (1)