Bowral

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.

Researchers are evaluating BGB-43395, a selective CDK4 inhibitor, as a single treatment and in combination with fulvestrant, letrozole, or elacestrant for participants with hormone receptor positive HR and HER2-negative breast cancer as well as other advanced solid tumors. This phase 1a1b study aims to determine the recommended dosing of BGB-43395 while assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. The study has multiple parts Phase 1a involves dose escalation with increasing doses of BGB-43395 alone or combined with the other drugs to evaluate safety and tolerability. Selected dose levels then move to Phase 1a safety expansion cohorts with combinations in HRHER2- breast cancer. Phase 1b tests the recommended dose for expansion RFDE of BGB-43395 combined with fulvestrant or letrozole in HR breast cancer, including a subgroup receiving an anti-diarrheal agent to prevent side effects. Treatments are administered orally or by injection depending on the drug. Participants undergo regular monitoring for adverse events, dose tolerability, and response rates over up to approximately 60 months. Blood samples are taken to measure drug levels and metabolism during treatment cycles lasting 28 days. Researchers assess tumor response, disease control, and progression-free survival. The study also tracks safety events and collects pharmacokinetic data to guide dosing. Participation may last up to several years depending on treatment duration and follow-up assessments.