Table of contents
- Trial overview
- Who the study is for
- Study design and phases
- What the trial measures
- Treatments used in the study
- What this means for patients
Trial overview
The available trial record shows one interventional study of GSK5733584 in advanced solid tumors, including gynecological tumors.[1] The study is authorised and plans to enroll 392 people.[1]
This trial is designed to test GSK5733584 together with other anti-cancer treatments, rather than studying it alone.[1] The goal is to learn whether the combinations are safe and whether they may help control cancer.[1]
Who the study is for
The trial focuses on people with advanced solid tumors, which are cancers that form a mass in an organ or tissue and have become more advanced.[1] The condition list also includes gynecological tumors, meaning cancers in the female reproductive system.[1]
The source data does not give the full enrollment rules, so it is not possible to list every who-can-join detail from the provided record.[1] What is clear is that the study is aimed at patients with advanced cancer who may need combination treatment.[1]
Study design and phases
This is an interventional study, which means researchers actively give treatments and then measure the effects.[1] The record describes it as a Phase I/II study and also lists the phase as Phase 1.[1]
In Part A, Dose Exploration, the study aims to find the recommended Phase 2 dose for each treatment combination.[1] In simple terms, this part checks how much treatment can be given safely before moving to later testing.[1]
In Part B, Dose Expansion, the study gives the chosen treatment approach to more participants so researchers can look more closely at anticancer activity.[1]
What the trial measures
The main safety measures in Part A are dose-limiting toxicities, adverse events, immune-mediated adverse events, adverse events of special interest, and serious adverse events.[1] These terms describe side effects, from common problems to more serious health issues that may happen during the study.[1]
The main activity measure in Part B is confirmed overall response rate, assessed by the investigator using RECIST 1.1.[1] This means the researchers check scans to see how many tumors shrink or disappear in a confirmed way.[1]
The study summary also says the trial wants to evaluate the anticancer activity of GSK5733584 in combination with other anti-cancer treatments.[1] That makes the trial important for learning both safety and possible benefit.[1]
Treatments used in the study
The record lists several treatments that may be used with GSK5733584: carboplatin, Avastin, cisplatin, and JEMPERLI.[1] These are given by intravenous use, meaning through a vein.[1]
Carboplatino Hikma is listed as one of the combination drugs in the trial.[1]
Avastin is also listed as part of the study combinations.[1]
Cisplatino Accord Healthcare Italia appears in the trial record as another combination treatment.[1]
JEMPERLI is listed as an additional treatment used with GSK5733584 in the study.[1]
What this means for patients
For patients, this trial is mainly about finding out whether GSK5733584 can be safely combined with other cancer treatments in advanced solid tumors.[1] The study is not just looking at side effects; it is also looking for early signs that the treatment may help the cancer respond.[1]
Because the trial is still in an early phase, the main focus is learning, not proving a final treatment benefit.[1] The results from this study may help decide whether larger future trials should be done.[1]
