EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)
ConditionAdvanced Solid Malignancy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrey Wolf Therapeutics
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Module 1 (GRWD5769 on its own as monotherapy)
- Module 2 (GRWD5769 in combination with cemiplimab, administered IV)
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov