RecruitingPhase 1NCT05628870

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

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.


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

102 participants

Start Date

Feb 7, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral endocrine therapy drug called HRS-1358 in women with locally advanced or metastatic breast cancer whose tumors are hormone receptor-positive (respond to estrogen). It is for patients who have already received at least one prior hormone therapy in the advanced setting. **You may be eligible if...** - You are a woman with confirmed advanced or metastatic breast cancer - Your cancer is hormone receptor-positive - You are postmenopausal, or if premenopausal/perimenopausal, you are receiving ovarian suppression - You have received at least one prior hormone therapy for advanced disease - Your general health and organ function are adequate (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is not considered suitable for hormone-based treatment - You have uncontrolled or active brain metastases with clinical symptoms - You have a history of significant heart or stroke disease - You have an active autoimmune disease or immune deficiency (including HIV) - You have had a prior organ transplant - You have had prior treatment with a similar drug to HRS-1358 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-1358

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


Locations(1)

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

Beijing, Beijing Municipality, China

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NCT05628870


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