Phase II Evaluation of HRS-6209 Combined with Fulvestrant or Letrozole for Safety and Effectiveness in Adults with HR-PositiveHER2-Negative Solid Tumors

What this Trial Is About

Researchers are studying the safety, tolerability, how the body processes, and the effectiveness of HRS-6209 in adults with hormone receptor-positive and HER2-negative solid tumors, including breast cancer. This Phase 1 trial aims to understand these aspects in patients with this type of cancer. The study is sponsored by Atridia Pty Ltd. and focuses on evaluating this combination treatment to provide more information for future care options. Participants will receive HRS-6209 capsules at a dose of 100 mg twice daily for four weeks along with a single dose of fulvestrant injection. This combination therapy is given as the experimental treatment. The trial follows a single group design without a comparison group, focusing on this combinations effects and safety during the treatment period. During the study, participants will be monitored for adverse events and serious side effects from screening through about one year after enrollment. Researchers will also measure the drug concentrations in the body up to four months and evaluate tumor response and disease control for up to two years. Participants can expect regular visits and assessments to track safety, response to treatment, and disease progression throughout the study period.

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