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OncoMatch/Clinical Trials/NCT06923761

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

Is NCT06923761 recruiting? Yes, currently enrolling (Jun 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.

Phase 1/2RecruitingGrey Wolf TherapeuticsNCT06923761Data as of Jun 2026Location: International · 4 countries

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.

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Extracted eligibility criteria

Treatments studied

Other

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

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.

Frequently asked questions

Is NCT06923761 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior ERAP1 inhibitor, checkpoint inhibitor disqualifies patients from enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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