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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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)

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Module 1 (GRWD5769 on its own as monotherapy)Experimental treatment 1 intervention
Group B: Module 2 (GRWD5769 in combination with cemiplimab, administered IV)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of treatment emergent and treatment related AEs

Incidence of treatment emergent and treatment related AEs assessed from start of study drug to 30 days post last dose of GRWD5769 (Module 1) or to 90 days post last dose of cemiplimab (Module 2 Parts A-C).

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.
2

Incidence of Dose limiting toxicities (DLT)

Incidence of Dose limiting toxicities (DLT) during the DLT period which commences Cycle 0 Day 1 and continues to 21 days after Cycle 1 Day 1

Time frame
End of cycle 1 (each cycle is 21 days)
3

Comparative efficacy (for Module 2D only)

Comparative efficacy will be evaluated or assessed using the change in dimension over time of RECIST Target Lesions from baseline and on-study scans recorded at weeks 8 and 16

Time frame
From baseline to week 16

Secondary outcomes

1

GRWD5769 Plasma PK Trough concentration

Time frame
Up to approximately 1 year
2

Objective response rate (ORR)

Preliminary efficacy of GRWD5769 will be assessed by: Tumour response (ORR) by RECIST 1.1 or iRECIST as determined by CT/MRI scans performed every 8 weeks until participant disease progression or withdrawal.

Time frame
Up to approximately 1 year
3

Disease specific tumour markers

Changes in any applicable disease-specific tumour markers assessed pre-treatment, Day 1 of each cycle from Cycle 2 onwards, at each 6-weekly safety extension visit, at the end of study visit and at follow up visit 30 days post last dose of GRWD5769.

Time frame
Up to approximately 1 year
4

GRWD5769 Plasma PK Cmax

Cmax = Maximum observed concentration

Time frame
Up to approximately 1 year

Other outcomes

Sponsors and contacts

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Grey Wolf Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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