A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer

Browse trials for

• Breast Neoplasms 12,544

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 15 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Study arms

• Experimental
  HRS-6209 Capsules and fulvestrant injection

  Drug: HRS-6209 Capsules and fulvestrant injection

Interventions

• DrugHRS-6209 Capsules and fulvestrant injection

  HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection

Primary outcomes

1. Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),

   To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer

   Time frame: Screening up to study completion,, an average of 1 year.

Secondary outcomes

1. Concentration

   Plasma concentrations of HRS-6209 during multiple dosing, directly observed from data.

   Time frame: From administration to Cycle2 , up to 4 months.

2. Cmax,ss

   Css, max are steady-state maximum concentrations of HRS-6209 during multiple dosing, and are directly observed from data.

   Time frame: From administration to Cycle2, up to 4 months.

3. Cmin,ss

   Css, min are the steady-state trough concentrations of HRS-6209 during multiple dosing, and are directly observed from data.

   Time frame: From administration to Cycle2, up to 4 months.

4. Objective Response Rate (ORR)

   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.

   Time frame: Screening up to study completion, an average of 2 years.

5. Best of Response (DoR)

   BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).

   Time frame: Screening up to study completion, an average of 2 years.

6. Disease Control Rate (DCR)

   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.

   Time frame: Screening up to study completion, an average of 2 years.

7. rPFS (radiographic progression-free survival

   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.

   Time frame: Screening up to study completion, an average of 2 years.