In short
Clinical trials are investigating GVV858 in people with advanced HR+/HER2- breast cancer and other advanced solid tumors. These studies look at safety, tolerability, and the best dose range, and they also test GVV858 alone or with endocrine therapy. The main phase is Phase 1/2.
Key points
- Clinical trials of GVV858 are studying people with advanced HR+/HER2- breast cancer, with the trial title also mentioning other advanced solid tumors. The study is in Phase 1/2, so it is designed to first check safety and find the best dose range, then look more closely at safety and tolerability. GVV858 is being tested alone and together with endocrine therapy such as fulvestrant or letrozole. Researchers are measuring dose-limiting toxicities, adverse events, serious adverse events, and changes in lab tests, vital signs, and ECGs. The planned enrollment is 85 participants, and the study status is Authorised.
Trial overview
The study of GVV858 is an interventional study, which means researchers give a treatment and then observe the results. It is authorised and planned to enroll 85 people.
The trial title says it is studying GVV858 as a single agent or in combination with endocrine therapy in patients with HR+/HER2- breast cancer and other advanced solid tumors.
Who the study is for
The main condition listed in the trial data is advanced HR+/HER2- breast cancer. HR+/HER2- means the cancer has hormone receptors and does not have high HER2 levels, which helps define the cancer type.
The title also mentions other advanced solid tumors, so the study is not limited only to breast cancer in its wording. However, the condition field specifically highlights advanced HR+/HER- breast cancer.
What is being tested
GVV858 is being tested as a single agent, which means by itself, and also in combination with endocrine therapy. Endocrine therapy is treatment that changes hormone signals that can help some cancers grow.
The trial data lists combination partners including fulvestrant and letrozole, and it also lists hormone-lowering medicines such as goserelin and leuprorelin acetate. The brief summary says Phase I will assess GVV858 as a single agent and in combination with fulvestrant or letrozole.
Study phase and goals
This is a Phase 1/2 trial, which is an early stage of clinical research. Phase 1 usually focuses on safety and dose finding, while Phase 2 looks more closely at safety and tolerability in a larger group.
The brief summary says Phase I aims to assess safety and tolerability and to identify the recommended dose or dose range for further clinical evaluation. Phase II aims to further characterize the safety and tolerability of GVV858 in combination with fulvestrant.
What researchers measure
The main outcomes in Phase I include dose-limiting toxicities, adverse events, serious adverse events, and changes in lab values, vital signs, and electrocardiograms (ECGs). Dose-limiting toxicities are side effects that are serious enough to limit how much treatment can be given.
The study also measures tolerability by tracking dose interruptions, dose reductions, discontinuations, and dose intensity. In Phase II, the study continues to measure safety and tolerability using the same types of checks, including adverse events, serious adverse events, lab values, vital signs, and ECGs.
These outcomes help researchers understand whether GVV858 can be given safely and how well people can stay on treatment.