[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Iksuda Therapeutics Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"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":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100506277","phase-1-iks014-in-advanced-solid-tumors-that-express-her2-100506277",false,"NCT05872295","IKS014 in Advanced Solid Tumors That Express HER2","A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors","Key Inclusion Criteria:\n\n* HER2 positive solid tumors with expression defined as IHC3+, IHC2+\u002FISH+, or low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH- \u002F+ or untested).\n* Participants with HR positive BC must have received prior treatment with a CDK4\u002F6 inhibitor, in countries where this is standard therapy.\n* Platelets ≥ 75,000 \u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Absolute neutrophil count ≥ 1000\u002FmcL\n* No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 2 weeks prior to first study drug administration\n* Creatinine clearance \\> 45\u002FmL\u002Fmin (using the Cockcroft-Gault equation)\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 if no liver metastases or \\\u003C 3 x ULN with Gilbert's Syndrome or liver metastases at baseline\n* Albumin \\> 2.5 g\u002FdL\n* Prothrombin time or international normalized ratio (INR) and either partial thromboplastin time (PTT) or activated (a) PTT ≤ 1.5 x ULN, ≤ 3 x institutional ULN if anticoagulated.\n* Must have adequate treatment washout period before trial treatment, defined as: Major surgery (≥ 4 weeks) and radiation therapy (≥ 3 weeks; in case of palliative radiation ≥ 2 weeks)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS)\n* Part 2 Dose Expansion Cohorts May Include:\n\n  1. Advanced or metastatic BC that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH, as per ASCO-CAP and previously treated with at least two HER2 directed treatments.\n  2. Advanced or metastatic BC that has low HER2 expression defined as IHC2+ (ISH-) or IHC1+ (ISH-\u002F+ or untested) and previously treated with at least 1 prior line of therapy which may include chemotherapy and\u002For a HER2 directed ADC.\n  3. Advanced or metastatic GC or GEJ cancer that is confirmed HER2-positive defined as IHC 3+ or IHC 2+ and evidence of HER2 amplification by ISH as per ASCO-CAP and previously treated with at least 1 prior line of therapy, which may include chemotherapy and\u002For a HER2 directed ADC.\n  4. Advanced or metastatic solid tumor that has been treated with standard of care therapy and is HER2 positive (HER2 IHC3+) as per ASCO-CAP or metastatic NSCLC (that has been treated with standard of care therapy) with a known activating HER2 (ERBB2) mutation.\n  5. Advanced or metastatic adenocarcinoma of the Esophagus that has been treated with at least one prior line of standard treatment, which may have included a HER2-directed therapy. The tumor must be HER2 positive defined either HER2 IHC3+ or HER2 IHC 2+\u002FISH+.\n\nKey Exclusion Criteria:\n\n* History of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n* Any clinically apparent ≥ Grade 2 pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the trial enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis), or prior pneumonectomy.\n* Current evidence of ≥ Grade 2 keratitis or other corneal abnormality.\n* Evidence of a clinically significant (≥ Grade 2) abnormality on slit-lamp examination or other clinically significant ophthalmologic finding, as determined by an ophthalmologist.\n* Evidence of clinically significant (≥ Grade 2) confluent superficial keratitis, a corneal epithelial defect, a corneal ulcer, or stromal opacity.\n* Participant must not use contact lenses while participating in this study.\n* Central nervous system metastatic disease unless treated with definitive local therapy (surgical resection, stereotactic radiotherapy, or whole brain radiotherapy) and participant is clinically, radiologically and neurologically stable for at least 4 weeks prior to the first dose of study drug not on steroid therapy or are on a stable or decreasing dose of steroids for at least 7 days prior to first dose of study drug. Prophylactic anticonvulsant medications are allowed.\n* Active second malignancy or history of another malignancy within the last 2 years with the exception of:\n\n  * Treated, non-melanoma skin cancers\n  * Treated carcinoma in situ (CIS) (e.g., breast, cervix)\n  * Controlled, superficial carcinoma of the urinary bladder\n  * T1a or b carcinoma of the prostate treated according to local standard of care, with prostate specific antigen (PSA) within normal limits (WNL) for the institution\n  * Papillary thyroid carcinoma Stage I treated surgically for cure\n* Clinically significant cardiovascular disease or condition\n* Clinically significant liver disease\n* Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks prior to first trial drug administration.\n* Any other serious, life-threatening, or unstable preexisting medical condition (aside from the underlying malignancy), including significant organ system dysfunction, or clinically significant laboratory abnormality(ies), which, in the opinion of the Investigator, would either compromise the participant's safety or interfere with obtaining informed consent, compliance with trial procedures, or evaluation of the safety of the trial drug.","ALL","18 Years",{"count":19,"type":20},165,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.",[26,27,28],"Breast Cancer","Gastric Cancer","Gastroesophageal-junction Cancer",[30,31,32,33,34,35,36,37],"HER2","IKS014","Low HER2","Advanced tumors","HER2+","HER2-positive","HER2 expression","GEJ","RECRUITING","2026-05-04",{"date":41,"type":42},"2026-05-08","ACTUAL",{"date":44,"type":42},"2023-09-14",{"date":46,"type":20},"2027-12",{"name":48,"class":49},"Iksuda Therapeutics Ltd.","INDUSTRY",13,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":50},"100467353","phase-1-iks03-in-patients-with-advanced-b-cell-non-hodgkin-lymphomas-100467353","NCT05365659","IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas","A Phase 1 Cohort Dose Escalation and Expansion Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas (NHL)","Inclusion Criteria:\n\n1. Males or females, ≥ 18 years of age\n2. Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible\n3. Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:\n\n   1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)\n   2. Follicular lymphoma (including duodenal-type follicular lymphoma)\n   3. Mantle cell lymphoma\n   4. B cell lymphomas not specified\n4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response\n5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy\n6. Must be in need of systemic treatment and not require immediate cytoreductive therapy\n7. Part 1: measurable or non-measurable disease\n8. Part 2: measurable disease according to The Revised Criteria\u002FLugano Classification\n9. Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy\n10. ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks\n11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.\n12. Ability to understand and give written informed consent\n\nExclusion Criteria:\n\n1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding\n2. Patients documented to be CD19-negative\n3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement\n4. Part 2: History of another malignancy within 2 years, with the exception of:\n\n   1. Treated, non-melanoma skin cancers\n   2. Treated carcinoma in situ (e.g., breast, cervix)\n   3. Controlled, superficial carcinoma of the urinary bladder\n   4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits\n   5. Papillary thyroid carcinoma Stage I treated surgically for cure\n5. Any of the following hematologic abnormalities at baseline (transfusion allowed \\> 5 days previous):\n\n   1. Hemoglobin \\\u003C 8.0 g\u002FdL\n   2. Absolute neutrophil count \\\u003C 1,000 per mm3\n   3. Platelet count \\\u003C 75,000 per mm3\n6. Any of the following laboratory abnormalities at baseline:\n\n   1. Total bilirubin \\> 1.5 × upper limit of normal (ULN); \\> 3 × ULN if with Gilbert's Syndrome\n   2. AST or ALT \\> 3 × ULN; \\> 5 × ULN if due to hepatic involvement by tumor\n   3. Estimated GFR ≤ 60 mL\u002Fmin corrected for BSA\n   4. Albuminuria defined as urine albumin to creatinine ratio \\\u003C 30 mg\u002Fg or \\\u003C 3 mg\u002Fmmol) by spot urine albumin\n7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:\n\n   1. PT or INR \\> 1.5 × ULN; \\> 3× ULN if anticoagulated)\n   2. PTT \\> 1.5 × ULN; \\> 3× ULN if anticoagulated\n8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:\n\n   1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin, corrected for BSA.\n   2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 30 mg\u002Fg or ≥ 3 mg\u002Fmmol by spot urine albumin\n9. Patients with:\n\n   1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable\n   2. Active uncontrolled bleeding or a known bleeding diathesis\n10. Significant cardiovascular disease or condition, including:\n\n    1. Congestive heart failure or angina pectoris requiring therapy\n    2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia\n    3. Severe conduction disturbance (e.g., 3rd degree heart block)\n    4. QTc interval ≥ 480 milliseconds\n    5. Left ventricular ejection fraction below the lower limit of normal or \\\u003C 50% by MUGA scan or echocardiogram\n    6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification\n    7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months\n11. Significant liver disease, including:\n\n    1. Non-infectious hepatitis\n    2. Hepatic cirrhosis (Child-Pugh Class B and Class C)\n12. Significant pulmonary disease or condition, including:\n\n    1. Significant symptomatic COPD, as assessed by the Investigator\n    2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis\n    3. History of pulmonary inflammatory disease, pneumonitis, ARDS\n    4. History of pneumonia within 6 months\n13. Significant corneal disease or condition, including history of or current evidence of keratitis\n14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months\n15. Known HIV infection or AIDS\n16. Active hepatitis B virus or hepatitis C virus infection\n17. Any other serious\u002Factive\u002Funcontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \\> 38ºC within 2 weeks\n18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications\n19. Unresolved Grade \\> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and\u002For endocrine end-organ failure being adequately managed by HRT)\n20. Known or suspected hypersensitivity to any of the excipients of formulated study drug\n21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks\n22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)\n23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process\n\nDrugs and Other Treatments to be Excluded:\n\n1. Receipt of:\n\n   1. Any CD19-targeted therapy within 3 months\n   2. Any tumor vaccine within 6 weeks (must have progressed if previously received)\n2. Prior autologous\u002Fallogeneic CAR-T therapy if known to be CD19-negative after\n3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)\n4. Any other investigational treatments within 4 weeks\n5. Drugs known to impair renal function, including:\n\n   1. NSAIDS within 3 days\n   2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week\n   3. Bisphosphonates within 1 month\n6. Prior solid organ transplant\n7. Allogeneic HSCT within 6 months, or:\n\n   1. If receiving immunosuppression\n   2. If with active evidence of GVHD\n8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months\n9. Radiotherapy:\n\n   1. To target lesions within 4 weeks unless progression of the lesion has been documented\n   2. To non-target lesions within 1 week\n10. Live\u002Flive-attenuated vaccines against infectious diseases within 4 weeks\n11. Immunosuppressive or systemic glucocorticoid therapy (\\> 10 mg prednisone daily or equivalent) within 2 weeks\n12. Prophylactic use of hematopoietic growth factors within 1 week\n13. Herbal therapies and supplements within 2 weeks\n14. Strong inhibitors of cytochrome P450 within 2 weeks",{"count":59,"type":20},140,[23],"This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).",[63,64,65,66,67],"B-cell Non-Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Mantle Cell Lymphoma","B-cell Lymphoma",[69,70,71,72,73,74,75,76],"CD19","non-Hodgkin lymphoma","NHL","DLBCL","MCL","advance lymphoma","IKS03","lymphoma","2025-09-26",{"date":79,"type":42},"2025-10-01",{"date":81,"type":42},"2023-09-05",{"date":83,"type":20},"2028-09",{"name":48,"class":49},""]