Actively Recruiting
EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)
Led by Grey Wolf Therapeutics · Updated on 2026-01-28
300
Participants Needed
29
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Male or female aged 18 years or older
- ECOG performance status of 0 or 1
- Willing to allow access to stored tumor tissue and prior tumor imaging or biomarker data if available
- Able to take oral medications and willing to record daily adherence
- Female participants must be non-childbearing or have a negative pregnancy test and use highly effective contraception plus condom
- Male participants must use a condom and ensure their female partners use highly effective contraception if applicable
- Estimated life expectancy of at least 3 months as judged by the investigator
- Willing and able to comply with all study visits, treatments, lab tests, and procedures
- Have measurable disease according to RECIST 1.1 or iRECIST
- Have confirmed locally advanced or metastatic solid malignancy with no standard treatment available, or have declined or are intolerant to standard treatments
- For Module 1 and 2 Part B: have at least one tumor lesion suitable for biopsies and measurable disease excluding biopsy lesions
- For Module 2 Parts C and D: meet specific cohort criteria including cervical cancer, hepatocellular carcinoma, moderate to high tumor mutational burden solid tumors, or pMMR/MSS colorectal cancer with prior treatment requirements
You will not qualify if you...
- Prior treatment with an ERAP1 inhibitor
- Any other cancer within the past 3 years except cervical intraepithelial neoplasia or nonmelanoma skin cancer
- Unresolved side effects from previous treatments greater than Grade 1 except alopecia
- Active or recent autoimmune disease requiring immunosuppressive therapy or immunocompromised status
- Spinal cord compression or brain metastases unless stable and asymptomatic without steroids for 4 weeks
- Uncontrolled seizures
- Active infection requiring treatment within 14 days before first dose
- Severe or uncontrolled medical or psychiatric conditions
- Active bleeding disorders
- Organ transplant recipients
- Known active hepatitis B, C, or HIV infection
- Pregnant or breastfeeding
- Recent cytotoxic or other cancer treatments within 28 days or 5 half-lives prior to first dose
- Recent use of oral corticosteroids over 10 mg prednisone equivalent within 14 days unless for adrenal insufficiency
- Recent use of medications strongly affecting CYP3A4 enzymes within 14 days
- Recent blood transfusion within 7 days
- Impaired liver or kidney function or other liver problems making participation unsafe
- Inadequate bone marrow or organ function
- History of severe blood cell deficiencies due to prior therapy
- Significant heart problems or abnormal ECG findings
- Risk factors for abnormal heart rhythms
- Unlikely to comply with study requirements
- History of haemolytic anemia or marrow aplasia
- Live-virus vaccination within 28 days (seasonal flu or COVID vaccines without live virus allowed)
- History of severe pneumonitis or lung disease likely to affect participation
- For Module 2 parts and Module 1A crossover: prior checkpoint inhibitor discontinuation due to toxicity, hypersensitivity to cemiplimab, or severe immune-related adverse events
- For Module 2 Part D pMMR/MSS colorectal cancer: no purely peritoneal disease and no prior checkpoint inhibitor or immunotherapy
AI-Screening
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Trial Site Locations
Total: 29 locations
1
GenesisCare Research
Adelaide, Australia
Withdrawn
2
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, Australia
Actively Recruiting
3
Blacktown Hospital
Blacktown, Australia
Actively Recruiting
4
Kinghorn Cancer Centre (KCC)
Darlinghurst, Australia
Actively Recruiting
5
Austin Health
Heidelberg, Australia
Actively Recruiting
6
Alfred Health
Melbourne, Australia
Actively Recruiting
7
Mater Research
South Brisbane, Australia
Actively Recruiting
8
Cancer Care Wollongong
Wollongong, Australia
Actively Recruiting
9
Centre Léon Bérard
Lyon, France
Actively Recruiting
10
Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
11
Centre Eugène Marquis
Rennes, France
Actively Recruiting
12
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, France
Actively Recruiting
13
ICANS - Institut de Cancérologie Strasbourg
Strasbourg, France
Actively Recruiting
14
IUCT Oncopole - Institut Claudius Regaud
Toulouse, France
Actively Recruiting
15
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
16
Hospital Universitario Vall d'Hebrón (VHIO)
Barcelona, Spain
Actively Recruiting
17
START Barcelona - Hospital HM Nou Delfos
Barcelona, Spain
Actively Recruiting
18
Clinica Universitaria de Navarra Madrid
Madrid, Spain
Actively Recruiting
19
START Madrid - Centro Integral Oncológico Clara Campal (HM CIOCC)
Madrid, Spain
Actively Recruiting
20
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
21
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
22
Clinica Universitaria de Navarra Pamplona
Pamplona, Spain
Actively Recruiting
23
INCLIVA-Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
24
Western General Hospital
Edinburgh, United Kingdom
Actively Recruiting
25
Clatterbridge Cancer Centre
Liverpool, United Kingdom
Actively Recruiting
26
Hammersmith Hospitals NHS Trust
London, United Kingdom
Actively Recruiting
27
Royal Free Hospital
London, United Kingdom
Actively Recruiting
28
Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
29
Newcastle Upon Tyne Hospital
Newcastle, United Kingdom
Actively Recruiting
Research Team
G
Grey Wolf Therapeutics Patient enquiries
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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