Breast Cancer
Conditions
Brief summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
Interventions
DRUGHRS-6209 Capsules and fulvestrant injection
HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection
Sponsors
Atridia Pty Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial. 2. Adequate bone marrow and other vital organ functions 3. Adequate liver function tests 4. HR-positive or HER2-negative solid tumor patients
Exclusion criteria
1. Plan to receive any other anti-tumor therapy during the study. 2. Active brain metastases . 3. Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure. 4. Previous use of fulvestrant 5. clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding. 6. With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease). 7. With acute or active tuberculosis infection requiring medication. 8. Pregnant or lactating women, or females planning to become pregnant During the study. 9. Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs), | Screening up to study completion,, an average of 1 year. | To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration | From administration to Cycle2 , up to 4 months. | Plasma concentrations of HRS-6209 during multiple dosing, directly observed from data. |
| Cmax,ss | From administration to Cycle2, up to 4 months. | Css, max are steady-state maximum concentrations of HRS-6209 during multiple dosing, and are directly observed from data. |
| Cmin,ss | From administration to Cycle2, up to 4 months. | Css, min are the steady-state trough concentrations of HRS-6209 during multiple dosing, and are directly observed from data. |
| Objective Response Rate (ORR) | Screening up to study completion, an average of 2 years. | ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline. |
| Best of Response (DoR) | Screening up to study completion, an average of 2 years. | BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE). |
| Disease Control Rate (DCR) | Screening up to study completion, an average of 2 years. | DCR refers to the time from the first occurrence of CR or PR to PD or death from any cause, whichever occurs first, in subjects with objective response. DCR will be recorded from baseline visit until the end of the study. |
| rPFS (radiographic progression-free survival | Screening up to study completion, an average of 2 years. | rPFS refers to the time from the first dose of investigational drug to the first radiographic PD or death from any cause (whichever occurs first) as assessed by the investigator. rPFS will be recorded from baseline visit until the end of the study. |
Countries
Australia
Contacts
CONTACTKathy You
CONTACTRavi Patel
Outcome results
None listed