[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"msi-hdmmr-gastric-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:msi-hdmmr-gastric-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100613133","phase-1-eik1005-002-a-clinical-research-study-evaluating-eik1005-a-werner-helicase-inhibitor-as-monotherapy-and-in-combination-with-pembrolizumab-in-participants-with-advanced-solid-tumors-including-microsatellite-instability-high-msi-h-tumors-100613133",false,"NCT07262619","EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors","A Multicenter, Multi-Part, Phase 1\u002F2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors","Key Inclusion Criteria:\n\n1. is ≥ 18 years of age at the time of signing the informed consent.\n2. has a life expectancy of at least 3 months.\n3. has histologically or cytologically documented advanced (unresectable and\u002For metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a central laboratory.\n4. In Part 1A, has received and then progressed after or is intolerant to at least 1 standard treatment regimen in the advanced setting. The participant does not have alternative therapeutic options per PI's medical judgement. Preference should be given to: (1) participants with MSI-H or dMMR cancers that have progressed after checkpoint inhibitor (CPI) therapy and (2) participants with microsatellite stable cells (MSS) cancers that have progressed following at least one regimen of platinum, alkylating or topoisomerase containing chemotherapy.\n5. has measurable disease at baseline according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by the PI.\n6. has an Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.\n7. has an adequate organ and marrow function.\n\nKey Exclusion Criteria:\n\n1. has not recovered (i.e., to Grade ≤ 1 or to baseline) from prior anti-cancer therapy-induced adverse events (AEs).\n2. has received prior treatment with Werner (WRN) inhibitor.\n3. has a history of relevant drug hypersensitivity, ascertained or presumptive allergy\u002Fhypersensitivity to the active drug substance and\u002For formulation ingredients, history of serious allergic reactions leading to hospitalization, or any other allergic reaction in general.\n4. In Parts 1B and Part 2 Rescue: diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n5. has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n6. has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.\n7. has mean resting QTcF \\> 470 ms (men and women) obtained from triplicate electrocardiograms (ECGs).\n8. has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Participants may enroll with the following conditions: Type 1 diabetes, hypothyroidism requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia not requiring systemic treatment).\n9. has history of (non-infectious) pneumonitis\u002Fpneumonitis\u002Finterstitial lung disease that required steroids or current pneumonitis\u002Finterstitial lung disease.\n10. has active tuberculosis.\n11. has any active infections requiring systemic therapy.","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.",[27,28,29,30,31,32,33],"Advanced Solid Tumors","MSI-H or dMMR Advanced Solid Tumors","MSI-H\u002FdMMR Gastric Cancer","MSI-H\u002FdMMR Colorectal Cancer","MSI-H\u002FdMMR Gastroesophageal-junction Cancer","Endometrial Cancer","Mismatch Repair Deficient or MSI-High Solid Tumors",[35,36,37,38,39,40,27,41,42,43,44,45,46],"Werner helicase","WRN","MSI-H","dMMR","DNA mismatch repair","EIK1005","Metastatic","MSI-H\u002FdMMR Endometrial Cancer","MSI-H\u002FdMMR Prostate Cancer","Pembrolizumab","Mismatch Repair Deficient (dMMR)","Microsatellite Instability High (MSI-H)","RECRUITING","2026-04-06",{"date":50,"type":51},"2026-04-08","ACTUAL",{"date":53,"type":51},"2026-01-20",{"date":55,"type":20},"2029-03",{"name":57,"class":58},"Eikon Therapeutics","INDUSTRY",10,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100535300","phase-2-zimberelimab-anti-pd1---domvanalimab-in-resectable-mmrd-gastric-cancer-100535300","NCT06250036","Zimberelimab Anti-PD1 +\u002F- Domvanalimab in Resectable Mmrd Gastric Cancer","A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +\u002F- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma","ZODIAC","Inclusion criteria\n\n* Age: ≥18 years\n* Histologically confirmed gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein classification type I-III (62))\n* MMRd\u002FMSI-H. There are three different methods validated for detection (63) :\n\n  * Immunohistochemistry (IHC) staining for expression of MMR proteins (MLH1, MSH2, PMS2 and MSH6), MMRd defined as loss of function or one or more of these proteins.\n  * Polymerase chain reaction (PCR) amplification of microsatellite sequences\n  * Next-generation sequencing (NGS) for detection of MSI\n  * Stage II-IIIB: TNM T2-T4, N0-N3, M0\n* Absence of distant metastatic disease on CT scan + PET CT + staging laparoscopy prior to study entry.\n* MDT determined suitable for surgery and MDT believes an R0 resection is achievable after neo-adjuvant therapy (resectable disease)\n* No prior anti-cancer therapy for gastric \u002F GOJ adenocarcinoma\n* ECOG performance status 0-2\n\nLaboratory parameters\n\n• Adequate haematologic and end-organ function defined by the following laboratory test results: Haematology: Absolute neutrophil count \\> 1.5 x 109\u002FL Platelets \\> 100 x 109\u002FL Haemoglobin \\> 90 x 109\u002FL (can be post-transfusion) Biochemistry: Serum Creatinine Clearance \\>50ml\u002Fmin (calculated using Cockcroft-Gault formula Appendix X)\n\nLiver function: Bilirubin within normal limits ALT\u002FAST ≤2.5x ULN\n\nCoagulation profile (for patients not receiving therapeutic anticoagulation):\n\nInternational Normalised Ratio (INR) \\\u003C 1.5 Activated Prothrombin Time (APTT) \\\u003C 1.5xULN\n\n* Before patient registration\u002Frandomisation, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment in the surgical \u002F oncology clinic\n* Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment\n* Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans\n\nExclusion criteria\n\nPatients are not eligible for the trial if any of the exclusion criteria below are met:\n\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3CTCAE v5.0, any history of anaphylaxis\n* Any prior treatment with cancer immunotherapy including anti-PD-1, anti-TIGIT, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Treatment with systemic immunosuppressive medications, including but not limited to: corticosteroids (dose of \\> 10mg\u002Fday prednisone equivalent) cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor \\[TNF\\] agents) within 2 weeks prior to Cycle 1 Day 1\n* Prior malignancy active within the previous 2 years except for:\n* locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix\n* localised prostate cancer\n* breast cancer diagnosed \\>2 years ago, now on adjuvant endocrine therapy (no known active disease)\n* Patients recommended to have radiotherapy as part of routine management for their gastric\u002FGOJ AC are ineligible\n\nQTc ≥480 msec using Fredericia QT correction formula\n\n* Metastatic disease on imaging or staging laparoscopy - visualisation of peritoneal disease on staging laparoscopy is an exclusionPrior organ transplantation, including allogeneic stem-cell transplantation\n* Any active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is expected to deteriorate when receiving immunotherapy, with the following exceptions:\n* Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n* Patients only receiving hormone replacement therapy e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy (doses ≤10mg - or equivalent - of prednisolone per day) for adrenal or pituitary insufficiency) are eligible\n* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only not requiring immunosuppressive treatment are eligible, providing they meet the following conditions\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\n* Rash mush cover less than 10% of body surface area\n* Disease is well controlled at baseline and only requiring low-potency topical steroids\n* No acute exacerbations of underlying condition within the last 12 months\n* Patients with controlled type 1 diabetes mellitus on a stable dose of insulin regimen are eligible\n* Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement\n* Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal intra-ocular, or inhalation) are acceptable. Steroids as pre-medication for hypersensitivity reactions e.g., CT contrast are also acceptable\n* History of inflammatory bowel disease with the following exception:\n* Patients with a history of ulcerative colitis who have had a colectomy are eligible\n* Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis\n* Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the 6 months prior to Cycle 1 Day 1\n* Cardiovascular diseases as follows:\n* Myocardial infarction within the previous year\n* Serious cardiac arrhythmia requiring medication (for example, ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate \\> 110bpm)\n* Unstable angina\n* Congestive cardiac failure (New York Heart Association Classification Class III or IV), EF \\\u003C50%\n* Active infection requiring systemic therapy, non-healing wound, ulcer or bone fracture requiring therapy\n* Major surgery, major trauma within 28 days prior to registration (not including staging laparoscopy)\n* Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease other than directly related to gastric\u002FGOJ adenocarcinoma, which in the opinion of the investigator, might impair the subject's tolerance of trial treatment or procedures\n* Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) active suicidal ideation or behaviour\n* Active\u002F uncontrolled Hepatitis A, B or C infection, for hepatitis B known positive HBV surface antigen (HBsAg) result, patients with past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are only eligible if polymerase chain reaction is negative for HCV RNA.\n* Uncontrolled human immunodeficiency virus (HIV) infection\n* If known HIV diagnosis and well controlled on anti-retrovirals (CD4 count ≥350cells\u002Ful and undetectable viral load) patient is eligible, ensure HIV team involvement for management and monitoring whilst on treatment\n* Use of live attenuated vaccine within 28 days of initiation of study therapy, or anticipation that a live attenuated vaccine will be required during the study\n* Pregnancy must be excluded with a negative serum pregnancy test, within 3 days before initiation of therapy, if the risk of conception exists. Sexually active female patients must be surgically sterile or be postmenopausal or must agree to use highly effective contraception. Sexually active male patients must be surgically sterile or must agree to use highly effective contraception, i.e. methods with a failure rate of \\\u003C1% per year (see section 5.4 for full definition and examples of highly effective contraception)\n* Lactation-breast-feeding is contraindicated and must be discontinued for the duration of the study period and for the required duration of the contraception use after the last dose of the study drug.\n* Any patient specific factors which are likely to interfere with compliance of trial specific procedures or treatment, including any medical or psychiatric conditions that in the investigator's or sponsor's opinion poses an undue risk to the participant's participation in the study or may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.",{"count":69,"type":20},50,[24],"A phase II study of peri-operative anti-PD1 (Zimberelimab) +\u002F- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)\u002F high micro-satellite instability (MSI-H) gastric\u002Fgastro-oesophageal junctional (GOJ) adenocarcinoma (AC)",[73,29,31],"Locally Advanced Gastric Adenocarcinoma",[38,75,37,76,77,78,79,80,81,82,66],"MMRd","gastric adenocarcinoma","GEJ adenocarcinoma","Gastroesophageal-junction adenocarcinoma","Peri-operative","MMRd\u002FMSI-H operable gastric\u002FGEJ adenocarcinoma","domvanalimab","zimberelimab","2025-08-19",{"date":85,"type":51},"2025-08-21",{"date":87,"type":51},"2025-02-20",{"date":89,"type":20},"2031-09-01",{"name":91,"class":92},"Royal Marsden NHS Foundation Trust","OTHER",9]