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 – Module 2.

ACTRN 12623001077651

Brief Summary

This study aims to assess a new cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs drug, GRWD5769, in patients with advancedat a late stage, far along cancer.

Intervention/Treatment

• Drug: GRWD5769

Inclusion Criteria

Module 2A & 2B

1. 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.
2. Participant has measurable disease per RECIST 1.1/iRECIST.

Module 2B specific

1. Participant has at least one tumoura tissue mass that forms from groups of unhealthy cells 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 2C specific

1. Participants with histologically confirmed persistent, recurrent or metastatic cervical cancer (SCC, adenocarcinomacancer arising from mucus-producing glands in organs, and adenosquamous carcinomacancer arising from tissues that line organs) who are not amenable to curative therapy.
2. Participants with histologically confirmed hepatocellular carcinoma who are not amenable to curative therapy and ineligible for loco-regional therapy.
3. 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 adenocarcinoma, oesophageal SCC).