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

ConditionAdvanced Unresectable or Metastatic Breast Cancer
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

This trial does not accept healthy volunteers

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, histopathologically confirmed ER-positive or PR-positive;

Having had bilateral oophorectomy, or aged ≥ 60 years old; or

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;

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-6209 in Combination with Fulvestrant

    Drug

    HRS-6209 in Combination with Fulvestrant

  • HRS-6209 in Combination with HRS-1358

    Drug

    HRS-6209 in Combination with HRS-1358

  • HRS-6209 in Combination with Letrozole

    Drug

    HRS-6209 in Combination with Letrozole

  • HRS-6209 in Combination with HRS-8080

    Drug

    HRS-6209 in Combination with HRS-8080

  • HRS-6209 in Combination with HRS-1358

    Drug

    HRS-6209 in Combination with HRS-1358

Treatment groups

528 Participants
are divided into 5 treatment groups
Group A: Treatment group A: HRS-6209 in Combination with FulvestrantExperimental treatment 1 intervention
Group B: Treatment group E: HRS-6209 in Combination with HRS-1358Experimental treatment 1 intervention
Group C: Treatment group B：HRS-6209 in Combination with LetrozoleExperimental treatment 1 intervention
Group D: Treatment group C：HRS-6209 in Combination with HRS-8080Experimental treatment 1 intervention
Group E: Treatment group D：HRS-6209 in Combination with HRS-1358Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT (dose-limiting toxicity)-Stage I (dose exploration)

Time frame
28 days after the first dose
2

MTD (maximum tolerated dose) -Stage I (dose exploration)

Time frame
28 days after the first dose
3

RP2D (recommended phase II dose) -Stage I (dose exploration)

Time frame
28 days after the first dose
4

(Serious) AEs-Stage I (dose exploration)

Time frame
every week in Cycle 1 (28 days after the first dose), every 2 weeks in Cycle 2 (28 days after the second dose), every 4 weeks from Cycle 3 and thereafter (28 days after each dose), lasting about one year

Secondary outcomes

1

Cmax, ss (Stage I)

Time frame
Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)
2

Tmax, ss (Stage I)

Time frame
Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)
3

Cmin, ss(Stage I)

Time frame
Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)
4

AUCss (Stage I)

Time frame
Cycle 1 (each cycle is 28 days) day 15、Cycle 2 (each cycle is 28 days) and Cycle 3 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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