Overview

“A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects with Advanced Solid Tumors”

This study is being done to learn more about a new investigational cancer treatment called GSK5733584. This treatment is a type of antibody-drug conjugate (a targeted therapy) designed to find and attack cancer cells that express a protein called B7‑H4. This protein is found on many tumor types, including ovarian and endometrial cancers, but appears at low levels in normal cells.

Why is this study being done?

Researchers want to understand: Whether GSK5733584 is safe for people to take How well people tolerate it How the body absorbs and processes the drug Whether the treatment shows early signs of shrinking or controlling tumors.

Who can take part?

Adults (18+) with advanced solid tumors can participate if: Their cancer has come back, grown, or stopped responding to standard treatments They have platinum‑resistant ovarian cancer or advanced/recurrent endometrial cancer, or another advanced solid tumor that no longer responds to care They can safely undergo study tests and meet specific health criteria.

How is the study organized?

The study has two parts:

Phase 1a (Dose‑Escalation) Small groups receive increasing doses to find the safest dose range. Helps determine side effects and how the drug moves through the body.
Phase 1b (Dose‑Expansion) Larger groups receive selected doses to understand how well the treatment works in specific cancers, especially: Platinum‑resistant ovarian cancer Endometrial cancer.

What does participation involve?

Participants will: Receive GSK5733584 through an IV infusion every 3 weeks Have regular blood tests, scans (CT/MRI), heart tests (ECG/ECHO), and tumor marker tests (like CA‑125 for ovarian cancer) Provide tumor samples (archival or newly collected) and optional blood samples for research Complete optional quality‑of‑life questionnaires.

How long will participants be followed?

Treatment continues as long as the cancer is not getting worse and side effects are manageable. After stopping the drug, participants will be followed for safety for about 90 days and have periodic check‑ins for survival information.

What are the possible benefits?

Participants may or may not directly benefit. Early data from another study suggests this treatment may help control or shrink certain cancers, but much more research is needed. Participants receive close monitoring from the study team. The information gathered may help future patients.

What are the possible risks?

Like most cancer treatments, this drug may cause side effects. In earlier studies, the most common have included: Blood‑related changes (low white cells, anemia, low platelets) Nausea and vomiting Mild liver test changes Protein in urine Rare cases of lung inflammation (pneumonitis)

All participants are monitored closely, and the study includes rules to modify or stop treatment if needed.

Why this research matters:

Many people with advanced ovarian, endometrial, and other solid tumors have limited treatment options after standard care stops working. This study aims to explore whether a new targeted therapy may help fill that gap.