A modular, multi-part, multi-arm, open-label, phase I/II study to evaluate the safety and tolerability of GRWD5769 alone and in combination with anticancer treatments in patients with solid malignancies

This study is open to adults aged 18 and older who have an advanced or metastatic solid tumour. 'Advanced' or 'metastatic' means the cancer has grown into nearby tissues or spread to other parts of the body, and standard curative treatments are no longer an option.

To join, participants need to be generally well enough to carry out light daily activities (an ECOG score of 0 or 1), be able to swallow tablets, and have an estimated life expectancy of at least three months. You must also agree to share past tumour samples and scan records with the study team.

Because this is a first-in-human trial with unknown effects on pregnancy, women who can have children must have negative pregnancy tests and use highly reliable contraception alongside condoms. Men taking part must also use condoms and avoid fathering a child or donating sperm during the study. Some specific groups in the trial may also need to have a tumour that can be safely biopsied.

Taking part involves regular hospital visits, especially in the first few weeks. GRWD5769 is taken as a tablet by mouth, and you will need to keep a daily diary of when you take it. If you are also receiving cemiplimab, it will be given as an infusion through a vein in your arm at the clinic.

Because safety is the top priority, you will have frequent health checks. These include physical exams, heart tests, scans (such as CT or MRI), and regular blood tests to measure drug levels. You may occasionally need to stay overnight in hospital for early morning or late-night blood sampling. Some participants will also be asked to have small tumour samples (biopsies) taken before and during treatment. The study opened in 2023 and runs until 2028, and you will remain in the study for as long as the treatment helps you and does not cause troublesome side effects.