RecruitingPhase 1/2

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

Australia300 participantsStarted 2023-05-21

Plain-language 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

Age range18 Years

SexALL

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Inclusion criteria

✓. Provision of written informed consent.
✓. Male or female, ≥ 18 years of age.
✓. An ECOG performance status of 0 or 1.
✓. Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments and tumour biomarker data (if available).
✓. Able to take oral medications and be willing to record daily adherence to the study drug.
✓. 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).
✓. 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.
✓. Estimated life expectancy of at least 3 months, in the opinion of the PI.

Exclusion criteria

✕. Prior therapy with an ERAP1 inhibitor.
✕. Any other malignancy within the past 3 years, with the exception of cervical intraepithelial neoplasia and nonmelanoma skin cancer.
✕. Any unresolved toxicity (except alopecia) from prior therapy of ≥ CTCAE Grade 1. Participants with Grade 2 toxicity that is not clinically significant (e.g., alopecia, vitiligo), or that is deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
✕. Active or documented history of autoimmune disease (within 2 years) requiring systemic immunosuppressive therapy, or participant is immunocompromised for any other reason (as determined by the Investigator).
✕. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks (if stable and requiring no intervention, the participant can be enrolled in the study).
✕. Uncontrolled seizures.
✕. Active infection requiring therapy within 14 days prior to the day of first dose of IMP.
✕. Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary disease, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition.

What they're measuring

Number of treatment emergent and treatment related AEs

Timeframe: From first dose to 30 days after last dose of GRWD5769 for Module 1 and 90 days after last dose of cemiplimab for Module 2 Parts A-C.

Incidence of Dose limiting toxicities (DLT)

Timeframe: End of cycle 1 (each cycle is 21 days)

Comparative efficacy (for Module 2D only)

Timeframe: From baseline to week 16

Trial details

NCT IDNCT06923761

SponsorGrey Wolf Therapeutics

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Grey Wolf Therapeutics Patient enquiries

+44 1235644970 enquiries@gwt.bio

View on ClinicalTrials.gov More Advanced Solid Malignancy trials