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

NCT05628870 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-03-17

No results posted yet for this 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).

Conditions

Interventions

DRUG

HRS-1358

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

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05628870 on ClinicalTrials.gov