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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination With Anticancer Treatments in Patients With Solid Malignancies

EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1) (NCT06923761) is a Phase 1 / Phase 2 interventional studying Advanced Solid Malignancy, sponsored by Grey Wolf Therapeutics. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Malignancy, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Provision of written willing to sign a consent form. 2. Male or female, ≥ 18 years of age. 3. An You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 4. Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments and tumour biomarker data (if available). 5. Able to take oral medications and be willing to record daily adherence to the study drug. 6. Female participants must be of non-child-bearing potential, or, if of childbearing potential must have a negative pregnancy test (as required by protocol), must use a highly effective method of contraception combined with a condom and not donate ova (for the protocol specified period of time). 7. Male participants must use a condom and their female participant must also use a highly effective method of contraception (for the protocol specified period of time), if engaging in sexual intercourse with a female partner who could become pregnant and not donate sperm. 8. Estimated expected to live at least 3 months, in the opinion of the PI. 9. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Participant has tumors that can be measured on scans 1.1/iRECIST 11. Participant has cytologically or diagnosed by tissue sample (biopsy-confirmed) locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy. Module 1 (Part B) and Module 2 (Part B) Only 12. Participant has at least one tumour lesion amenable to serial biopsies and is willing to provide consent for biopsies and has tumors that can be measured on scans 1.1/iRECIST, excluding the lesion(s) identified for biopsy. Module 2 (Part C and Part D) Cohort 1 (Cervical) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Provision of written informed consent. 2. Male or female, ≥ 18 years of age. 3. An ECOG performance status of 0 or 1. 4. Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments and tumour biomarker data (if available). 5. Able to take oral medications and be willing to record daily adherence to the study drug. 6. Female participants must be of non-child-bearing potential, or, if of childbearing potential must have a negative pregnancy test (as required by protocol), must use a highly effective method of contraception combined with a condom and not donate ova (for the protocol specified period of time). 7. Male participants must use a condom and their female participant must also use a highly effective method of contraception (for the protocol specified period of time), if engaging in sexual intercourse with a female partner who could become pregnant and not donate sperm. 8. Estimated life expectancy of at least 3 months, in the opinion of the PI. 9. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Participant has measurable disease per RECIST 1.1/iRECIST 11. Participant has cytologically or histologically confirmed locally advanced or metastatic solid malignancy for which no further standard of care (SoC) therapy is available (or no SoC therapy exists), or who have been offered and declined SoC therapy, or are intolerant of SoC therapy. Module 1 (Part B) and Module 2 (Part B) Only 12. Participant has at least one tumour lesion amenable to serial biopsies and is willing to provide consent for biopsies and has measurable disease per RECIST 1.1/iRECIST, excluding the lesion(s) identified for biopsy. Module 2 (Part C and Part D) Cohort 1 (Cervical) 13. Participants with histologically confirmed persistent, recurrent or metastatic cervical cancer who are not amenable to curative therapy. 14. Participants should have received 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. 15. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI. Cohort 2 (Hepatocellular Carcinoma) 16. Participants with histologically confirmed hepatocellular carcinoma who are not amenable to curative therapy and ineligible for loco-regional therapy. 17. Participants should have received 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. 18. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI. 19. Participant has Child-Pugh score class A liver function. Cohort 3 (Moderate to High TMB) 20. Participants with cytologically or histologically confirmed advanced, recurrent or metastatic disease, which is not amenable to curative therapy, in up to 5 types of solid tumour with moderate to high median TMB (NSCLC, urothelial, SCCHN, gastric/gastro-oesophageal adenocarcinoma, oesophageal SCC). 21. Participants should have received 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. 22. Participants may enrol in the study immediately following progression on the first line CPI or may have received 1 further line of systemic cancer therapy after progression on CPI. Module 2 Part D only (pMMR/MSS-CRC) 23. Participants with histologically confirmed unresectable pMMR/MSS-CRC, without current or prior liver metastases 24. Participants 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 25. Participants may not have received more than 2 lines of cytotoxic chemotherapy Exclusion Criteria: 1. Prior therapy with an ERAP1 inhibitor. 2. Any other malignancy within the past 3 years, with the exception of cervical intraepithelial neoplasia and nonmelanoma skin cancer. 3. 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. 4. 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). 5. Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring steroids for at least 4 weeks (if stable and requiring no intervention, the participant can be enrolled in the study). 6. Uncontrolled seizures. 7. Active infection requiring therapy within 14 days prior to the day of first dose of IMP. 8. Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary disease, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition. 9. Active bleeding diatheses. 10. Participant has received an organ transplant. 11. Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection (HIV). 12. Participant is breastfeeding or pregnant. 13. Receipt of licenced or unlicenced cytotoxic, noncytotoxic or small molecule treatment for the malignancy within 28 days or 5 half-lives, whichever is shorter prior to the day of first dose of IMP. 14. Receipt of oral corticosteroids (at a dose \> 10 mg prednisone/day or equivalent) within 14 days (except for subjects receiving corticosteroids for adrenal insufficiency). 15. Receipt of St John's Wort or of another concomitant medication, herbal supplement, or food that is a strong inhibitor or inducer of CYP3A4 enzymes within 14 days. 16. Receipt of a blood transfusion (blood or blood products) within 7 days. 17. Impaired hepatic or renal function. 18. Liver function deteriorating in a manner that would likely make the participant ineligible per protocol specified requirements. 19. Other evidence of impaired hepatic synthesis function. 20. Inadequate bone marrow reserve or organ function. 21. Any 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). 22. Cardiac dysfunction or other clinically significant cardiac pathology likely to impair the participants ability to participate in the study. 23. Mean QTcF \> 450 ms for males or \> 470 ms for females. 24. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG. Controlled atrial fibrillation is permitted. 25. Any factor that in the Investigator's opinion increases the risk of QTc prolongation or arrythmic events. 26. In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements. 27. A history of haemolytic anaemia or marrow aplasia. 28. Has received a live-virus vaccination within 28 days. Note: seasonal flu or COVID vaccines that do not contain live virus are permitted. 29. History of Grade 3 or 4 pneumonitis or interstitial lung disease within the last 5 years, or other clinically significant pulmonary pathology likely to impair ability to participate in the study. Module 2 all Parts and Module 1A Crossover Participants Only 30. Has discontinued a prior checkpoint inhibitor due to toxicity. 31. Hypersensitivity to cemiplimab or any of its excipients, or contraindicated to cemiplimab per approved local labelling. 32. Has experienced ≥ Grade 2 immune-mediated AE on this study (applies to crossover participants only). Module 2 Part D only - pMMR/MSS CRC dose optimisation cohort 33. Participants with unresectable pMMR/MSS CRC may not have purely peritoneal disease 34. Participants with unresectable pMMR/MSS CRC may not have had prior CPI / immunotherapy

Treatments Being Tested

DRUG

Module 1 (GRWD5769 on its own as monotherapy)

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)

DRUG

Module 2 (GRWD5769 in combination with cemiplimab, administered IV)

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)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GenesisCare Research
Adelaide, Australia
Southern Oncology Clinical Research Unit (SOCRU)
Bedford Park, Australia
Blacktown Hospital
Blacktown, Australia
Kinghorn Cancer Centre (KCC)
Darlinghurst, Australia
Austin Health
Heidelberg, Australia
Alfred Health
Melbourne, Australia
Mater Research
South Brisbane, Australia
Cancer Care Wollongong
Wollongong, Australia
Centre Léon Bérard
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Centre Eugène Marquis
Rennes, France
Institut de Cancérologie de l'Ouest (ICO)
Saint-Herblain, France
ICANS - Institut de Cancérologie Strasbourg
Strasbourg, France
IUCT Oncopole - Institut Claudius Regaud
Toulouse, France
Institut Gustave Roussy
Villejuif, France
Hospital Universitario Vall d'Hebrón (VHIO)
Barcelona, Spain
START Barcelona - Hospital HM Nou Delfos
Barcelona, Spain
Clinica Universitaria de Navarra Madrid
Madrid, Spain
START Madrid - Centro Integral Oncológico Clara Campal (HM CIOCC)
Madrid, Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06923761), the sponsor (Grey Wolf Therapeutics), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06923761 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06923761?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06923761?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06923761. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06923761. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.