EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)
This is a Phase I/II, open-label, first-in human study of GRWD5769 alone, and in combination with another anti-cancer agent in advanced solid cancers.
| Condition(s) | Advanced Solid Malignancy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a Phase I/II, open-label, first-in human study of GRWD5769 alone, and in combination with another anti-cancer agent in advanced solid cancers. |
| Who can participate | Inclusion Criteria: 1. Provision of written informed consent. 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 tumour tissue 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 contracept |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Grey Wolf Therapeutics |
| Locations | Adelaide, Australia; Bedford Park, Australia; Blacktown, Australia; Darlinghurst, Australia; Heidelberg, Australia; Melbourne, Australia (+23 more sites) |
| Start date | 2023-05-21 |
| NCT ID | NCT06923761 |
| Official listing | https://clinicaltrials.gov/study/NCT06923761 |