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