[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grey Wolf Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596610","phase-1-east-1-erap-inhibition-in-axial-spondyloarthritis-trial---1-100596610",false,"NCT07047703","EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)","A Multi-part, Phase I\u002FII Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis","EAST-1","Inclusion Criteria:\n\nHealthy Volunteers\n\n* Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit\n* Participant must provide written informed consent to participate in the study\n* Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice)\n* Male participants (and their female partners) \u002F female participants must be willing to adhere to contraception requirements as detailed in the protocol\n* Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit\n* Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) \u002F \\[Height (m)\\]2\n\nAxSpA Participants\n\n* Male or female, 18-65 years of age\n* Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including:\n\n  1. HLA-B27 +ve (local testing)\n  2. Objective evidence of inflammation at screening, specifically active sacroiliac joint inflammation on MRI fulfilling the ASAS MRI criteria (MRI+), assessed by the Principal Investigator or appropriately trained delegate, and\u002For elevated C-reactive protein (CRP+) ≥5.0mg\u002FL.\n* Symptom duration of ≥3 months\n* Age at onset of active disease of \\\u003C40 years\n* A score of ≥ 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n* At least one of the following:\n\n  1. Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR\n  2. Intolerance to ≥1 NSAID or contraindication(s) to NSAIDs\n* Participants may have received 1 prior\u002F(Australia only) 2 prior b\u002Fts DMARD and discontinued due to intolerance or inadequate efficacy.\n* Participants who have received 1\u002F(Australia only) 2 prior treatments are required to undergo a washout at minimum:\n\n  1. Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.\n  2. JAK inhibitor DMARDs 2 weeks prior to Day 1\n\nExclusion Criteria:\n\nHealthy Volunteers\n\n* History or presence of any clinically significant findings in medical history, physical examination, vital signs and\u002For laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study\n* Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days\n* Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and\u002For hepatitis B or C infection, as determined at the Screening visit\n\nAxSpA Participants\n\n* Participants who have received \\>1\u002F(Australia only) \\>2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic drugs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.\n* Inadequate Haematologic function, defined as:\n\n  1. Haemoglobin \\\u003C10 g\u002FdL.\n  2. Absolute white blood cell count \\\u003C3.0 x 109 \u002FL (\\\u003C3000 mm3)\n  3. Absolute neutrophil count \\\u003C1.2 x 109 \u002FL (\\\u003C1200 mm3)\n  4. Absolute lymphocyte count \\\u003C1.0 x 109 \u002FL (\\\u003C1000 mm3)\n  5. Platelet count \\\u003C100 x 109 \u002FL (\\\u003C100.000 mm3)\n* Inadequate liver function, defined as; total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal at screening visit. For subjects with Gilberts syndrome, upper limit of normal for total bilirubin will be 2.9mg\u002Fdl\n* History of any other autoimmune rheumatic disease (e.g., psoriatic arthropathy, systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymositis) or known diagnosis of fibromyalgia\n* Participants with a previous history of or currently stable psoriasis are eligible\n* Active or symptomatic inflammatory bowel disease (IBD). Participants with a history of IBD are allowed to participate\n* Presence of active anterior uveitis\n\nPlease note the following Country-Specific Inclusion Criteria, for study participants in Australia:\n\n\\- Participants with a score of ≥ 2.1 (High Disease Activity) on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n\nFor study participants in Part B only:\n\n* Objective evidence of inflammation may not be required for some participants with low to moderate disease activity.\n* Participants with an ASDAS score between ≥1.3 and \\\u003C 2.1 (Low to Moderate Disease Activity) will require Sponsor approval prior to screening for the study, as they may not require an MRI to provide objective evidence of inflammation if on current treatment. For participants with low to moderate disease activity, MRI should only be performed if required to confirm ASAS classification.\n\nFor axSpA participants in Part B, MRI assessment of the SI joints is only required for participant eligibility criteria evaluation to assess objective inflammation in case CRP measurement at baseline is negative and the objective evidence of inflammation is required.","ALL","18 Years","65 Years",{"count":21,"type":22},141,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","GRWD0715 is an orally administered, selective inhibitor of the Endoplasmic Reticulum Aminopeptidase 1 \\[ERAP1\\] enzyme being explored as a potential new treatment for axial spondyloarthritis (axSpA), a long term condition caused by inflammation predominantly affecting the sacroiliac joints (SIJs) and spine.",[29],"Axial Spondyloarthritis (AxSpA)",[31,32],"Axial Spondyloarthritis","AxSpA","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2025-07-28",{"date":41,"type":22},"2028-09-30",{"name":43,"class":44},"Grey Wolf Therapeutics","OTHER",16,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100587082","phase-1-emitt-1-erap-mediated-immunopeptidome-targeting-trial---1-100587082","NCT06923761","EMITT-1 (ERAP Mediated Immunopeptidome Targeting Trial - 1)","A Modular, Multi-part, Multi-arm, Open-label, Phase I\u002FII Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination With Anticancer Treatments in Patients With Solid Malignancies","EMITT-1","Inclusion Criteria:\n\n1. Provision of written informed consent.\n2. Male or female, ≥ 18 years of age.\n3. An ECOG performance status of 0 or 1.\n4. Willing to permit access to stored historical tumour tissue and prior tumour radiological assessments and tumour biomarker data (if available).\n5. Able to take oral medications and be willing to record daily adherence to the study drug.\n6. 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).\n7. 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.\n8. Estimated life expectancy of at least 3 months, in the opinion of the PI.\n9. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.\n10. Participant has measurable disease per RECIST 1.1\u002FiRECIST\n11. 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.\n\n    Module 1 (Part B) and Module 2 (Part B) Only\n12. 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\u002FiRECIST, excluding the lesion(s) identified for biopsy.\n\n    Module 2 (Part C and Part D)\n\n    Cohort 1 (Cervical)\n13. Participants with histologically confirmed persistent, recurrent or metastatic cervical cancer who are not amenable to curative therapy.\n14. 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.\n15. 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.\n\n    Cohort 2 (Hepatocellular Carcinoma)\n16. Participants with histologically confirmed hepatocellular carcinoma who are not amenable to curative therapy and ineligible for loco-regional therapy.\n17. 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.\n18. 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.\n19. Participant has Child-Pugh score class A liver function.\n\n    Cohort 3 (Moderate to High TMB)\n20. 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\u002Fgastro-oesophageal adenocarcinoma, oesophageal SCC).\n21. 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.\n22. 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.\n\n    Module 2 Part D only (pMMR\u002FMSS-CRC)\n23. Participants with histologically confirmed unresectable pMMR\u002FMSS-CRC, without current or prior liver metastases\n24. Participants should have received at least one line of therapy in the advanced\u002Fmetastatic setting and should have received therapies according to local standard practice, unless ineligible or intolerant to the treatment\n25. Participants may not have received more than 2 lines of cytotoxic chemotherapy\n\nExclusion Criteria:\n\n1. Prior therapy with an ERAP1 inhibitor.\n2. Any other malignancy within the past 3 years, with the exception of cervical intraepithelial neoplasia and nonmelanoma skin cancer.\n3. 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.\n4. 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).\n5. 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).\n6. Uncontrolled seizures.\n7. Active infection requiring therapy within 14 days prior to the day of first dose of IMP.\n8. Severe or uncontrolled medical condition (e.g., severe chronic obstructive pulmonary disease, severe Parkinson's disease, active inflammatory bowel disease) or psychiatric condition.\n9. Active bleeding diatheses.\n10. Participant has received an organ transplant.\n11. Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection (HIV).\n12. Participant is breastfeeding or pregnant.\n13. 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.\n14. Receipt of oral corticosteroids (at a dose \\> 10 mg prednisone\u002Fday or equivalent) within 14 days (except for subjects receiving corticosteroids for adrenal insufficiency).\n15. 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.\n16. Receipt of a blood transfusion (blood or blood products) within 7 days.\n17. Impaired hepatic or renal function.\n18. Liver function deteriorating in a manner that would likely make the participant ineligible per protocol specified requirements.\n19. Other evidence of impaired hepatic synthesis function.\n20. Inadequate bone marrow reserve or organ function.\n21. Any prior history of persistent (\\> 4 weeks) severe pancytopenia due to previous therapy rather than to disease (ANC \\\u003C 0.5 × 10\\^9\u002FL or platelets \\\u003C 50 x 10\\^9\u002FL).\n22. Cardiac dysfunction or other clinically significant cardiac pathology likely to impair the participants ability to participate in the study.\n23. Mean QTcF \\> 450 ms for males or \\> 470 ms for females.\n24. Any clinically important abnormalities in rhythm, conduction, or morphology on resting ECG. Controlled atrial fibrillation is permitted.\n25. Any factor that in the Investigator's opinion increases the risk of QTc prolongation or arrythmic events.\n26. In the opinion of the Investigator, unlikely to comply with study procedures, restrictions, or requirements.\n27. A history of haemolytic anaemia or marrow aplasia.\n28. Has received a live-virus vaccination within 28 days. Note: seasonal flu or COVID vaccines that do not contain live virus are permitted.\n29. 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.\n\n    Module 2 all Parts and Module 1A Crossover Participants Only\n30. Has discontinued a prior checkpoint inhibitor due to toxicity.\n31. Hypersensitivity to cemiplimab or any of its excipients, or contraindicated to cemiplimab per approved local labelling.\n32. Has experienced ≥ Grade 2 immune-mediated AE on this study (applies to crossover participants only).\n\n    Module 2 Part D only - pMMR\u002FMSS CRC dose optimisation cohort\n33. Participants with unresectable pMMR\u002FMSS CRC may not have purely peritoneal disease\n34. Participants with unresectable pMMR\u002FMSS CRC may not have had prior CPI \u002F immunotherapy",{"count":55,"type":22},300,[25,26],"This is a Phase I\u002FII, open-label, first-in human study of GRWD5769 alone, and in combination with another anti-cancer agent in advanced solid cancers.",[59],"Advanced Solid Malignancy",[61,62,63,64,65,66,67,68,69,70,71,72,73],"Oncology","ERAP 1","Solid tumors","TMB-H","NSCLC","Lung cancer","Cervical cancer","HCC - Hepatocellular Carcinoma","Liver cancer","Head and Neck Squamous Cell Carcinoma","SCCHN","Urothelial cancer","immuno oncology","2026-01-26",{"date":76,"type":37},"2026-01-28",{"date":78,"type":37},"2023-05-21",{"date":80,"type":22},"2028-04-30",{"name":43,"class":44},29,""]