EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial – 1) (EMITT-1)

• Drug: Module 1 (GRWD5769 on its own as monotherapy)
• Drug: Module 2 (GRWD5769 in combination with cemiplimab, administered IV)

Inclusion Criteria:

1. Provision of written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
2. Male or female, ≥ 18 years of age.
3. An ECOG performance status of 0 or 1.
4. Willing to permit access to stored historical tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function and prior tumour radiological assessments and tumour biomarker data (if available).
5. Able to take oral medications and be willing to record daily adherence to the study drug.
6. Female participants must be of non-child-bearing potential, or, if of childbearing potential must have a negative pregnancy test (as required by protocol), must use a highly effective method of contraception combined with a condom and not donate ova (for the protocol specified period of time).
7. Male participants must use a condom and their female participant must also use a highly effective method of contraception (for the protocol specified period of time), if engaging in sexual intercourse with a female partner who could become pregnant and not donate sperm.
8. Estimated life expectancy of at least 3 months, in the opinion of the PI.
9. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.Module 1 (Parts A, B and C) and Module 2 (Parts A and B)
10. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy.Module 1 (Parts A, B and C) and Module 2 (Parts A and B) only
11. Participant has measurable disease per RECIST 1.1/iRECIST.Module 1 (Part B) and Module 2 (Part B) Only
12. Participant has at least one tumour lesion amenable to serial biopsies and is willing to provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST, excluding the lesion(s) identified for biopsyremoval of a section of tissue to analyse for cancer cells.Module 2 (Part C) Cohort 1
13. Participants with histologically confirmed persistent, recurrent or metastatic cervical cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs who are not amenable to curative therapy.
14. Participants should have received at least 3 months first line anti-PD(L)-1 maintenance therapy (± bevacizumab) following combination with chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells + anti-PD-(L)1 ± bevacizumab and this should have included at least a 10-week period without progression.
15. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI.Cohort 2
16. Participants with histologically confirmed hepatocellular carcinomacancer arising from tissues that line organs who are not amenable to curative therapy and ineligible for loco-regional therapy.
17. Participants should have received at least 3 months first line anti-PD(L)-1 containing therapy and this should have included at least a 10-week period without progression per Investigator assessment.
18. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI.
19. Participant has Child-Pugh score class A liver function.Cohort 3
20. Participants with cytologically or histologically confirmed advanced, recurrent or metastatic disease, which is not amenable to curative therapy, in up to 5 types of solid tumour with moderate to high median TMB (NSCLC, urothelial, SCCHN, gastric/gastro-oesophageal adenocarcinomacancer arising from mucus-producing glands in organs, oesophageal SCC).
21. Participants should have received at least ≥ 3 months first line anti-PD(L)-1 either initiated as monotherapy or following completion of chemotherapy + anti PD-(L)1.
22. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI.