Table of Contents
- Trial overview
- Study design and treatment plan
- Who can participate
- What is being measured
- Trial status and size
Trial overview
The main trial for Gtaexs617 is NCT05985655, an open-label study, which means the treatment is not hidden from the people in the study or the research team.[1] It is also multicenter, meaning it is being carried out at more than one study site.[1] The study is for patients with advanced solid tumors.[1]
The trial is designed as a Phase 1/2 study.[1] In Phase 1, researchers focus on safety and dose finding, and in Phase 2 they look more closely at early signs that the treatment may help control the cancer.[1] The brief summary says the study aims to find a preliminary optimal biologic dose or recommended phase 2 dose, which means the dose that looks most suitable for later testing.[1]
Study design and treatment plan
The study is interventional, which means researchers assign the study treatment rather than just observing patients.[1] The brief summary says Gtaexs617 is being studied as monotherapy and in combination with selected standard of care regimens.[1] Monotherapy means treatment with one study drug, while standard of care means treatments already used in usual cancer care.
The listed combination treatments include Fulvestrant Ribosepharm, Capecitabine Accord, Paclitaxel Kabi, Caelyx pegylated liposomal, and Abevmy.[1] The trial record also shows that Gtaexs617 is given by oral use.[1] The source data do not explain which exact patient group receives each combination, so the article only reports that these regimens are part of the study design.[1]
Who can participate
The trial is for people with advanced solid tumors.[1] Solid tumors are cancers that form a mass in an organ or tissue, unlike blood cancers that start in the blood or bone marrow.
The source data do not list more detailed entry rules, such as prior treatments, age limits, or test results.[1] For this reason, the clearest patient-level description is that the study is aimed at people whose cancer is advanced and who fit the full study rules used by the trial team.[1]
What is being measured
The Phase 1 part measures dose-limiting toxicities during Cycle 1 of treatment.[1] Dose-limiting toxicities are side effects serious enough to affect how much treatment can be given. The study also measures adverse events, serious adverse events, and treatment-emergent adverse events, which are medical problems that happen during the study and may or may not be caused by the treatment.[1]
Another Phase 1 goal is to track safety parameters from baseline, meaning the researchers compare health measurements before treatment starts with later results.[1] The trial also looks at tolerability by measuring dose interruptions, dose reductions, and the dose intensity achieved.[1] Dose interruptions mean treatment is paused, dose reductions mean the amount is lowered, and dose intensity means how much treatment is actually delivered over time.
In Phase 2, the main effectiveness measure is objective response rate, or ORR, assessed using RECIST v1.1.[1] RECIST v1.1 is a standard way to judge whether tumors shrink, stay stable, or grow.[1] The trial also continues to measure safety, tolerability, and adherence, including use of a treatment diary.[1] Adherence means how well participants follow the study treatment plan and record information as asked.
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 280 participants, which is the number of people the study aims to include.[1] This size suggests a step-by-step research plan, starting with dose and safety work and then moving into a closer look at early tumor response.[1]
