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

Sponsor
Grey Wolf Therapeutics
Study ID
NCT06923761
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Module 1 (GRWD5769 on its own as monotherapy) — DRUG
    Module 1 will initially be conducted in 4 study parts: Part A: Monotherapy dose escalation (where the safety of increasing doses of GRWD5769 will initially be assessed in a small group of patients, overseen by a safety review committee) Part B: (Optional) Monotherapy dose expansion part (to look at the effect of GRWD5769 on the body, and of the body on GRWD5769, at particular dose levels to include evaluation of biopsies of tumour tissue) Part C: (Optional) Intra-patient dose escalation (where a patient may receive three different GRWD5769 doses so that blood levels at each dose can be measured in an individual) Part D: Monotherapy dose expansion group(s) (where a dose of GRWD5769 may be chosen to be evaluated in specific types of cancer)
  • Module 2 (GRWD5769 in combination with cemiplimab, administered IV) — DRUG
    Module 2 will initially be conducted as 3 study parts, similar to those above, but looking at GRWD5769 when given in combination with cemiplimab: Part A: Combination therapy dose escalation (like Module 1 Part A) Part B: (Optional) Combination therapy dose expansion part (like Module 1 Part B) Part C: Combination therapy dose expansion group(s) (where a dose of GRWD5769 given with cemiplimab will be evaluated in specific types of cancer) Part D: Randomised dose optimisation, combination therapy (where 3 doses of GRWD5769 given with cemiplimab will be evaluated in specific types of cancer)

Study Details

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.

Key Dates

Start date
May 21, 2023
Status verified
Jun 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 (GRWD5769 on its own as monotherapy)
  • Experimental: Module 2 (GRWD5769 in combination with cemiplimab, administered IV)

Primary Outcome Measure

Number of treatment emergent and treatment related AEs [ Time Frame: 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. ]

Central Contacts