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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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtridia Pty Ltd.

About this trial

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.

Adequate bone marrow and other vital organ functions

Adequate liver function tests

HR-positive or HER2-negative solid tumor patients

Disqualifiers

Plan to receive any other anti-tumor therapy during the study.

Active brain metastases .

Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.

Previous use of fulvestrant

Trial design

Design model

Single group

Treatments tested in this trial

  • HRS-6209 Capsules and fulvestrant injection

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: HRS-6209 Capsules and fulvestrant injectionExperimental treatment 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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

Atridia Pty Ltd.

Lead sponsor

Source ClinicalTrials.gov
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