OncoMatch/Clinical Trials/NCT06923761
EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)
Is NCT06923761 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Module 1 (GRWD5769 on its own as monotherapy) and Module 2 (GRWD5769 in combination with cemiplimab, administered IV) for advanced solid malignancy.
Treatment: Module 1 (GRWD5769 on its own as monotherapy) · Module 2 (GRWD5769 in combination with cemiplimab, administered IV) — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage III, IV
Participant has measurable disease per RECIST 1.1/iRECIST; locally advanced or metastatic solid malignancy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — first line
at least 3 months first line anti-PD(L)-1 therapy (± bevacizumab, chemotherapy, ADC or other immunotherapy e.g. anti-CTLA-4) and this should have included at least a 10-week period without progression
Must have received: anti-PD-1 therapy — first line
at least 3 months first line anti-PD(L)-1 containing therapy and this should have included at least a 10-week period without progression per Investigator assessment
Must have received: anti-PD-1 therapy — first line
at least ≥ 3 months first line anti-PD(L)-1 (± chemotherapy, ADC, pemetrexed or other immunotherapy e.g. anti-CTLA-4) and this should have included at least a 10-week period without progression
Must have received: — advanced/metastatic
should have received at least one line of therapy in the advanced/metastatic setting and should have received therapies according to local standard practice, unless ineligible or intolerant to the treatment
Cannot have received: ERAP1 inhibitor
Prior therapy with an ERAP1 inhibitor
Cannot have received: checkpoint inhibitor
Participants with unresectable pMMR/MSS CRC may not have had prior CPI / immunotherapy
Lab requirements
Blood counts
inadequate bone marrow reserve or organ function excluded; no prior history of persistent (> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC < 0.5 × 10^9/L or platelets < 50 x 10^9/L)
Kidney function
no impaired renal function
Liver function
Child-Pugh score class A liver function (for HCC); no impaired hepatic synthesis function; liver function not deteriorating per protocol
Cardiac function
cardiac dysfunction or other clinically significant cardiac pathology likely to impair participation excluded; mean QTcF > 450 ms for males or > 470 ms for females excluded; any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG excluded
Participant has Child-Pugh score class A liver function; impaired hepatic or renal function; liver function deteriorating; other evidence of impaired hepatic synthesis function; inadequate bone marrow reserve or organ function; cardiac dysfunction or other clinically significant cardiac pathology; mean QTcF > 450 ms for males or > 470 ms for females; any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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