Recruiting NCT07358377
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-6209 Capsules and fulvestrant injection.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Multi-Center Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant or Letrozole in Patients With Solid Tumor
Overview
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
Interventions
- Drug HRS-6209 Capsules and fulvestrant injection
HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection
Primary outcome measures
- Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs), [Time frame: Screening up to study completion,, an average of 1 year.]
Secondary outcome measures (7)
- Concentration [Time frame: From administration to Cycle2 , up to 4 months.]
- Cmax,ss [Time frame: From administration to Cycle2, up to 4 months.]
- Cmin,ss [Time frame: From administration to Cycle2, up to 4 months.]
- Objective Response Rate (ORR) [Time frame: Screening up to study completion, an average of 2 years.]
- Best of Response (DoR) [Time frame: Screening up to study completion, an average of 2 years.]
- Disease Control Rate (DCR) [Time frame: Screening up to study completion, an average of 2 years.]
- rPFS (radiographic progression-free survival [Time frame: Screening up to study completion, an average of 2 years.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
- With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
- With acute or active tuberculosis infection requiring medication.
- Pregnant or lactating women, or females planning to become pregnant During the study.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- Lyell McEwin Hospital — Elizabeth Vale
- Ballarat Base Hospital — Ballarat
- Frankston Hospital — Frankston
Identifiers
NCT: NCT07358377 · HRS-6209-205