A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer

Eligibility criteria

Qualifiers

Females aged 18-75 years (inclusive);

ECOG performance status (PS) score of 0-1;

Patients with histopathologically confirmed metastatic or unresectable locally advanced breast cancer;

Patients with advanced malignant solid tumors confirmed by histopathology or cytopathology, who have failed standard treatment, or for whom no effective standard treatment regimen is available, or who are unable to receive further standard treatment.

Disqualifiers

With symptomatic visceral metastases deemed unfit for endocrine therapy by the investigator;

With active brain metastases, carcinomatous meningitis, spinal cord compression, or a history of primary tumors of the central nervous system;

History of clinically significant cardiovascular disease, including;

Abnormal ECG findings, which are judged by the investigator to be clinically significant and and need to intervene;

Trial design

Treatments tested in this trial

  • HRS-6209 in Combination with Fulvestrant
  • HRS-6209 in Combination with HRS-1358
  • HRS-6209 in Combination with Letrozole
  • HRS-6209 in Combination with HRS-8080
  • HRS-6209 in Combination with HRS-1358
  • HRS-6209 in Combination with HRS-9813 and Letrozole
  • HRS-6209 in Combination with HRS-9813 and HRS-8080

Treatment groups

528 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.