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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;

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

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

  • HRS-6209 in Combination with HRS-9813 and Letrozole

    Drug

    HRS-6209 in Combination with HRS-9813 and Letrozole

  • HRS-6209 in Combination with HRS-9813 and HRS-8080

    Drug

    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.

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-8080Experimental treatment 1 intervention
Group F: Treatment group F: HRS-6209 in Combination with HRS-1358Experimental treatment 1 intervention
Group G: Treatment group G：HRS-6209 in Combination with HRS-9813 and LetrozoleExperimental treatment 1 intervention
Group H: Treatment group H：HRS-6209 in Combination with HRS-9813 and HRS-8080Experimental treatment 1 intervention
Group I: Treatment group I：HRS-6209 in Combination with HRS-9813 and HRS-8080Experimental 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) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (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) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (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) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (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) 、 Cycle 3 (each cycle is 28 days)、Cycle 4 (each cycle is 28 days)、、Cycle 5 (each cycle is 28 days)、Cycle 6 (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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