Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
HRS-6209-205
Clinical summary
Summary
Eligible participants will receive HRS-6209 capsules and fulvestrant hormone therapy as an injection. HRS-6209 will be taken twice a day, and fulvestrant will be given once.
Conditions
This trial is treating people with HR+ or HER2- solid tumours
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Atridia Pty Ltd.
Scientific 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
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