[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastro-esophageal-junctional-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastro-esophageal-junctional-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":24,"conditions":25,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100649839","phase-1-iks04-regimen-in-advanced-solid-tumors-that-express-ca242-100649839",false,"NCT07738939","IKS04 Regimen in Advanced Solid Tumors That Express CA242","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of the IKS04 Regimen Targeting CA242","Key Inclusion Criteria:\n\n* Advanced or metastatic CRC, BTCs, GEA, and PDAC that is histologically or cytologically confirmed\n* Disease that has progressed despite prior treatment, for which additional effective therapy is not available, not tolerable, is contraindicated, or the participant refuses standard therapy.\n* Platelets ≥ 100,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL., no transfusions with RBCs are allowed within 2 weeks prior to first trial drug administration\n* ANC ≥ 1500\u002FmcL\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN) ≤ 5 x ULN if liver metastases present\n* Total bilirubin ≤ 1.5 x ULN, unless participant has Gilbert's Syndrome\n* Albumin \\> 2.5 g\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n\nPart I\n\n* Fresh biopsy tissue or formalin-fixed paraffin-embedded (FFPE) tumor tissue block or slides available for retrospective assessment of CA242 positivity in a central laboratory.\n* Measurable and non-measurable disease\n\nPart II\n\n* Fresh biopsy tissue or FFPE tumor tissue block or slides for assessment of CA242 positivity in a central laboratory prior to administration of first dose of study drug.\n* Measurable disease only\n\nKey Exclusion Criteria:\n\n* Participants with a significant pulmonary disease or condition, including:\n\n  * Significant symptomatic chronic obstructive pulmonary disease (COPD), as assessed by the Investigator.\n  * History or any current evidence on imaging studies of interstitial lung disease (ILD), pulmonary fibrosis.\n  * History of pulmonary inflammatory disease, pneumonitis, acute respiratory distress syndrome (ARDS).\n  * History of pneumonia within 3 months prior to the first trial drug administration.\n* Participants who have received previous treatment with any CA242 directed ADC or any ADC containing a PBD payload for their current tumor indication.\n* Participant may not have received more than 5 prior lines of systemic therapy.\n* Received treatment with a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first trial drug administration\n* Central nervous system metastatic disease unless treated prior to first dose of trial drug.\n* Active second malignancy or history of another malignancy within the last 2 years with specific exceptions as per protocol\n* Active, known or suspected autoimmune disease, or a documented history of autoimmune disease or syndrome requiring systemic steroids or other immunosuppressive medications, such as:\n\n  * Myocarditis, pneumonitis, glomerulonephritis.\n  * Autoimmune hepatitis, inflammatory bowel disease (IBD)\n  * Sjogren's syndrome\n  * Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE)\n  * Myositis\n  * Myasthenia gravis\n  * Guillain-Barré Syndrome\n  * Multiple sclerosis\n  * Granulomatosis with polyangiitis (Wegner's granulomatosis)\n  * Vasculitis","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further evaluation in expansion (RDE). The regimen includes Isumab04 (unconjugated antibody) followed by the IKS04 antibody-drug conjugate, both directed against the CA242 (CanAg) tumor-associated antigen and administered intravenously (IV) in patients with advanced solid cancers.",[26,27,28,29,30,31,32,33],"Colorectal Cancer","Gastro Esophageal Junctional Cancer","Gastric Cancer (GC)","GEJ Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Biliary Tract Cancer (BTC)","Gall Bladder Cancer","Cholangiocarcinoma",[35,36,37,38],"CA242","advanced gastrointestinal tumors","IKS04","Isumab04","NOT_YET_RECRUITING","2026-07-27",{"date":42,"type":43},"2026-07-31","ACTUAL",{"date":45,"type":20},"2026-11",{"date":47,"type":20},"2029-12",{"name":49,"class":50},"Iksuda Therapeutics Ltd.","INDUSTRY",4]