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

Study acronym: EMITT-1
StatusRecruiting
PhasePhase 1/2
Started2023-05-21
View on ClinicalTrials.gov ↗

Amendment history

2026-01-26
minor
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Enrollment target288→300
Eligibility criteria+666 characters
[...] atment plans, laboratory tests, and other study procedures. ModuleParticipant has measurable disease per RECIST 1 (Parts A, B and C) and Module 2 (Parts A and B).1/iRECIST Participant has cytologically or histologically confirmed l [...] 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 Participant has measurable disease per RECIST 1.1/iRECIST. Module 1 (Part B) and Module 2 (Part B) Only Participant has [...] luding the lesion(s) identified for biopsy. Module 2 (Part C and Part D) Cohort 1 (Cervical) Participants with histologically co [...] [...]
Secondary endpoints14 to 17 entries
Number of treatment emergent and treatment related AEs (for Module 2D only) Incidence of Dose limiting toxicities (DLT) (for Module 2D only) Overall Survival
Primary endpoints2 to 3 entries
Comparative efficacy (for Module 2D only)
Study descriptionrevised
[...] fects of GRWD5769 when given alone and Module 2 (Parts A to CD) which will look at the effects of GRWD5769 when given in c [...]
Study sitesdetails revised at 1 of 29 sites
2025-11-18
minor
Study Status, Oversight, Contacts/Locations v2
Study sitesdetails revised at 1 of 29 sites
2025-06-18
minor
Study Status, Oversight, Conditions, Contacts/Locations v1
Study sitesdetails revised at 7 of 29 sites
2025-04-04
minor
Original filing
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.
Trial Details
NCT Number NCT06923761
Lead Sponsor Grey Wolf Therapeutics
Conditions Advanced Solid Malignancy
Enrollment 300 participants
Start Date 2023-05-21
Primary Completion 2027-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-28